| Product NDC: | 68391-352 |
| Proprietary Name: | Berkley and Jensen nicotine |
| Non Proprietary Name: | Nicotine Polacrilex |
| Active Ingredient(s): | 2 mg/1 & nbsp; Nicotine Polacrilex |
| Administration Route(s): | ORAL |
| Dosage Form(s): | GUM, CHEWING |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 68391-352 |
| Labeler Name: | BJWC |
| Product Type: | HUMAN OTC DRUG |
| FDA Application Number: | ANDA078547 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20080921 |
| Package NDC: | 68391-352-70 |
| Package Description: | 2 CARTON in 1 PACKAGE (68391-352-70) > 12 BLISTER PACK in 1 CARTON (68391-352-76) > 10 GUM, CHEWING in 1 BLISTER PACK |
| NDC Code | 68391-352-70 |
| Proprietary Name | Berkley and Jensen nicotine |
| Package Description | 2 CARTON in 1 PACKAGE (68391-352-70) > 12 BLISTER PACK in 1 CARTON (68391-352-76) > 10 GUM, CHEWING in 1 BLISTER PACK |
| Product NDC | 68391-352 |
| Product Type Name | HUMAN OTC DRUG |
| Non Proprietary Name | Nicotine Polacrilex |
| Dosage Form Name | GUM, CHEWING |
| Route Name | ORAL |
| Start Marketing Date | 20080921 |
| Marketing Category Name | ANDA |
| Labeler Name | BJWC |
| Substance Name | NICOTINE |
| Strength Number | 2 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes |