Pill Identifier Information of Haloperidol 10 MG Oral Tablet
Drug Information
Haloperidol 10 MG Oral Tablet
| Imprint: | ZC;08 |
| Shape: | C48345 |
| Color: | C48329 |
| Ingredients: | Haloperidol |
| Size: | 10.00 |
| Score: | 2 |
| Rxtty: | SCD |
| Author: | Cadila Healthcare Limited |
| Inactive Ingredients: | CALCIUM STEARATE / D&C YELLOW NO. 10 / DIBASIC CALCIUM PHOSPHATE DIHYDRATE / FD&C BLUE NO. 1 / POVIDONE K30 / SODIUM STARCH GLYCOLATE TYPE A POTATO / STARCH, CORN> |
Complete Information
- SPL UNCLASSIFIED SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-837-01 in bottle of 100 Tablets
Haloperidol Tablets USP, 0.5 mg
Rx only
100 Tablets
NDC 65841-838-01 in bottle of 100 Tablets
Haloperidol Tablets USP, 1 mg
Rx only
100 Tablets
NDC 65841-839-01 in bottle of 100 Tablets
Haloperidol Tablets USP, 2 mg
Rx only
100 Tablets
NDC 65841-626-01 in bottle of 100 Tablets
Haloperidol Tablets USP, 5 mg
Rx only
100 Tablets
NDC 65841-627-01 in bottles of 100 tablets
Haloperidol Tablets USP, 10 mg
Rx only
100 Tablets
NDC 65841-628-01 in bottles of 100 tablets
Haloperidol Tablets USP, 20 mg
Rx only
100 Tablets
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INGREDIENTS AND APPEARANCE
HALOPERIDOLÂ
haloperidol tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-626 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL 5 mg Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE (UNII: LMI26O6933)  CALCIUM STEARATE (UNII: 776XM7047L)  D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  POVIDONE K30 (UNII: U725QWY32X)  SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  STARCH, CORN (UNII: O8232NY3SJ)  Product Characteristics Color GREEN (GREEN) Score 2 pieces Shape OVAL (CAPSULE) Size 10mm Flavor Imprint Code ZC;07 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-626-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2008 2 NDC:65841-626-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077580 01/03/2008 HALOPERIDOLÂ
haloperidol tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-627 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL 10 mg Inactive Ingredients Ingredient Name Strength CALCIUM STEARATE (UNII: 776XM7047L)  D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  POVIDONE K30 (UNII: U725QWY32X)  SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  STARCH, CORN (UNII: O8232NY3SJ)  ALUMINUM OXIDE (UNII: LMI26O6933)  Product Characteristics Color GREEN (LIGHT GREEN) Score 2 pieces Shape OVAL (CAPSULE) Size 10mm Flavor Imprint Code ZC;08 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-627-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2008 2 NDC:65841-627-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077580 01/03/2008 HALOPERIDOLÂ
haloperidol tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-628 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL 20 mg Inactive Ingredients Ingredient Name Strength CALCIUM STEARATE (UNII: 776XM7047L)  D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  POVIDONE K30 (UNII: U725QWY32X)  SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  STARCH, CORN (UNII: O8232NY3SJ)  Product Characteristics Color ORANGE (CORAL) Score 2 pieces Shape OVAL (CAPSULE) Size 10mm Flavor Imprint Code ZC;09 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-628-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2008 2 NDC:65841-628-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077580 01/03/2008 HALOPERIDOLÂ
haloperidol tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-837 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL 0.5 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30)  MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  STARCH, CORN (UNII: O8232NY3SJ)  Product Characteristics Color WHITE (OFF-WHITE) Score score with uneven pieces Shape ROUND Size 6mm Flavor Imprint Code 15;11 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-837-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 2 NDC:65841-837-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 3 NDC:65841-837-77 10 in 1 CARTON 02/01/2023 3 NDC:65841-837-30 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077580 02/01/2023 HALOPERIDOLÂ
haloperidol tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-838 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL 1 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30)  MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  STARCH, CORN (UNII: O8232NY3SJ)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  Product Characteristics Color WHITE (PALE YELLOW) Score score with uneven pieces Shape ROUND Size 6mm Flavor Imprint Code 15;12 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-838-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 2 NDC:65841-838-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 3 NDC:65841-838-77 10 in 1 CARTON 02/01/2023 3 NDC:65841-838-30 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077580 02/01/2023 HALOPERIDOLÂ
haloperidol tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-839 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL 2 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30)  MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  STARCH, CORN (UNII: O8232NY3SJ)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  Product Characteristics Color PINK (Light Pink) Score score with uneven pieces Shape ROUND Size 7mm Flavor Imprint Code 15;13 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-839-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 2 NDC:65841-839-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 3 NDC:65841-839-77 10 in 1 CARTON 02/01/2023 3 NDC:65841-839-30 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077580 02/01/2023 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-626, 65841-627, 65841-628, 65841-837, 65841-838, 65841-839) , MANUFACTURE(65841-626, 65841-627, 65841-628, 65841-837, 65841-838, 65841-839)