PROMETHEGAN
- Product NDC
- 0713-0132
- 11-digit product format
- 007130132
- Labeler code
- 0713
- Product ID
- 0713-0132_0b625ebc-4f41-49d9-e063-6294a90a56ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- promethazine hydrochloride
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Labeler
- Cosette Pharmaceuticals, Inc.
- Application
- ANDA087165
- Marketing category
- ANDA
- Marketing start
- 1987-08-31
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Phenothiazine [EPC], Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PROMETHEGAN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PROMETHAZINE HYDROCHLORIDE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R61ZEH7I1I |
| Rxcui | 992478, 992481 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0713-0132-10 | PROMETHEGAN | 1000 in 1 BOX | SUPPOSITORY | 1000 | | 7 |
| 0713-0132-12 | PROMETHEGAN | 12 in 1 BOX | SUPPOSITORY | 12 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Promethazine Hydrochloride | ACTIVE INGREDIENT | R61ZEH7I1I | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] | 3 | |
| Promethazine Hydrochloride | ACTIVE INGREDIENT | R61ZEH7I1I | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| Promethazine | ACTIVE MOIETY | FF28EJQ494 | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] | 3 | |
| Promethazine | ACTIVE MOIETY | FF28EJQ494 | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| Ascorbyl Palmitate | INACTIVE INGREDIENT | QN83US2B0N | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] | 3 | |
| Ascorbyl palmitate | INACTIVE INGREDIENT | QN83US2B0N | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| Fat, Hard | INACTIVE INGREDIENT | 8334LX7S21 | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] | 3 | |
| Fat, Hard | INACTIVE INGREDIENT | 8334LX7S21 | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| Polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] | 3 | |
| Polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0713-0132 | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [COSETTE PHARMACEUTICALS, INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20231201_636bb9bc-0cc5-4d6a-85be-6471acf01ffc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0713-0132-10 | 00713013210 | 1000 SUPPOSITORY in 1 BOX (0713-0132-10) | 1000 suppository | 1987-08-31 | 0000-00-00 | No | No | Current |
| 0713-0132-12 | 00713013212 | 12 SUPPOSITORY in 1 BOX (0713-0132-12) | 12 suppository | 1987-08-31 | 0000-00-00 | No | No | Current |