promethazine hydrochloride
- Product NDC
- 57664-107
- 11-digit product format
- 576640107
- Labeler code
- 57664
- Product ID
- 57664-107_61563305-2f6b-e520-e053-2a91aa0a15c2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- promethazine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA040863
- Marketing category
- ANDA
- Marketing start
- 2009-01-27
- Marketing end
- 0000-00-00
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 13 mg/1
- Pharmacologic classes
- Phenothiazine [EPC],Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PROMETHAZINE HYDROCHLORIDE | ACTIVE INGREDIENT | R61ZEH7I1I | PROMETHAZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| PROMETHAZINE | ACTIVE MOIETY | FF28EJQ494 | PROMETHAZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PROMETHAZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | PROMETHAZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| D&C RED NO. 30 | INACTIVE INGREDIENT | 2S42T2808B | PROMETHAZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | PROMETHAZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | PROMETHAZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | PROMETHAZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PROMETHAZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed RxNorm Mappings#