| Product NDC: | 52959-534 |
| Proprietary Name: | Promethazine Hydrochloride |
| Non Proprietary Name: | Promethazine Hydrochloride |
| Active Ingredient(s): | 25 mg/1 & nbsp; Promethazine Hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 52959-534 |
| Labeler Name: | H.J. Harkins Company, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA040596 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20051214 |
| Package NDC: | 52959-534-45 |
| Package Description: | 45 TABLET in 1 BOTTLE (52959-534-45) |
| NDC Code | 52959-534-45 |
| Proprietary Name | Promethazine Hydrochloride |
| Package Description | 45 TABLET in 1 BOTTLE (52959-534-45) |
| Product NDC | 52959-534 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Promethazine Hydrochloride |
| Dosage Form Name | TABLET |
| Route Name | ORAL |
| Start Marketing Date | 20051214 |
| Marketing Category Name | ANDA |
| Labeler Name | H.J. Harkins Company, Inc. |
| Substance Name | PROMETHAZINE HYDROCHLORIDE |
| Strength Number | 25 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] |