| Product NDC: | 16571-600 |
| Proprietary Name: | CROMOLYN SODIUM |
| Non Proprietary Name: | CROMOLYN SODIUM |
| Active Ingredient(s): | 100 mg/5mL & nbsp; CROMOLYN SODIUM |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SOLUTION, CONCENTRATE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 16571-600 |
| Labeler Name: | Pack Pharmaceuticals, LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA202583 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20111205 |
| Package NDC: | 16571-600-96 |
| Package Description: | 12 POUCH in 1 CARTON (16571-600-96) > 8 AMPULE in 1 POUCH > 5 mL in 1 AMPULE |
| NDC Code | 16571-600-96 |
| Proprietary Name | CROMOLYN SODIUM |
| Package Description | 12 POUCH in 1 CARTON (16571-600-96) > 8 AMPULE in 1 POUCH > 5 mL in 1 AMPULE |
| Product NDC | 16571-600 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | CROMOLYN SODIUM |
| Dosage Form Name | SOLUTION, CONCENTRATE |
| Route Name | ORAL |
| Start Marketing Date | 20111205 |
| Marketing Category Name | ANDA |
| Labeler Name | Pack Pharmaceuticals, LLC |
| Substance Name | CROMOLYN SODIUM |
| Strength Number | 100 |
| Strength Unit | mg/5mL |
| Pharmaceutical Classes | Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] |