| Product NDC: | 0713-0526 |
| Proprietary Name: | PROMETHEGAN |
| Non Proprietary Name: | PROMETHAZINE HYDROCHLORIDE |
| Active Ingredient(s): | 25 mg/1 & nbsp; PROMETHAZINE HYDROCHLORIDE |
| Administration Route(s): | RECTAL |
| Dosage Form(s): | SUPPOSITORY |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0713-0526 |
| Labeler Name: | GW Laboratories, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA040428 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20020228 |
| Package NDC: | 0713-0526-10 |
| Package Description: | 1000 SUPPOSITORY in 1 BOX (0713-0526-10) |
| NDC Code | 0713-0526-10 |
| Proprietary Name | PROMETHEGAN |
| Package Description | 1000 SUPPOSITORY in 1 BOX (0713-0526-10) |
| Product NDC | 0713-0526 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | PROMETHAZINE HYDROCHLORIDE |
| Dosage Form Name | SUPPOSITORY |
| Route Name | RECTAL |
| Start Marketing Date | 20020228 |
| Marketing Category Name | ANDA |
| Labeler Name | GW Laboratories, Inc. |
| Substance Name | PROMETHAZINE HYDROCHLORIDE |
| Strength Number | 25 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] |