| Product NDC: | 54868-4794 |
| Proprietary Name: | Promethazine Hydrochloride |
| Non Proprietary Name: | Promethazine Hydrochloride |
| Active Ingredient(s): | 12.5 mg/1 & nbsp; Promethazine Hydrochloride |
| Administration Route(s): | RECTAL |
| Dosage Form(s): | SUPPOSITORY |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 54868-4794 |
| Labeler Name: | Physicians Total Care, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA040603 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20030520 |
| Package NDC: | 54868-4794-2 |
| Package Description: | 1 BLISTER PACK in 1 BOTTLE, PLASTIC (54868-4794-2) > 2 SUPPOSITORY in 1 BLISTER PACK |
| NDC Code | 54868-4794-2 |
| Proprietary Name | Promethazine Hydrochloride |
| Package Description | 1 BLISTER PACK in 1 BOTTLE, PLASTIC (54868-4794-2) > 2 SUPPOSITORY in 1 BLISTER PACK |
| Product NDC | 54868-4794 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Promethazine Hydrochloride |
| Dosage Form Name | SUPPOSITORY |
| Route Name | RECTAL |
| Start Marketing Date | 20030520 |
| Marketing Category Name | ANDA |
| Labeler Name | Physicians Total Care, Inc. |
| Substance Name | PROMETHAZINE HYDROCHLORIDE |
| Strength Number | 12.5 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] |