PROMETHEGAN
- Product NDC
- 0713-0536
- 11-digit product format
- 007130536
- Labeler code
- 0713
- Product ID
- 0713-0536_0b622b7b-a45f-eab0-e063-6394a90a0c0a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- promethazine hydrochloride
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Labeler
- Cosette Pharmaceuticals, Inc.
- Application
- ANDA040428
- Marketing category
- ANDA
- Marketing start
- 2004-02-28
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 12.5 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 | 12.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R61ZEH7I1I |
| Rxcui | 992441, 992445, 992454, 992459 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0713-0536-10 | PROMETHEGAN | 1000 in 1 BOX | SUPPOSITORY | 1000 | | 7 |
| 0713-0536-12 | 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 PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] | 2 | |
| Promethazine | ACTIVE MOIETY | FF28EJQ494 | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] | 2 | |
| Ascorbyl Palmitate | INACTIVE INGREDIENT | QN83US2B0N | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] | 2 | |
| Fat, Hard | INACTIVE INGREDIENT | 8334LX7S21 | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] | 2 | |
| Glyceryl Monostearate | INACTIVE INGREDIENT | 230OU9XXE4 | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] | 2 | |
| Silicon Dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] | 2 | |
| White Wax | INACTIVE INGREDIENT | 7G1J5DA97F | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0713-0536 | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [COSETTE PHARMACEUTICALS, INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20231201_5f079815-f48b-8b21-2130-7f791d967c9a.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 |
|---|
| 0713-0536-10 | 00713053610 | 1000 SUPPOSITORY in 1 BOX (0713-0536-10) | 1000 suppository | 2004-02-28 | 0000-00-00 | No | No | Current |
| 0713-0536-12 | 00713053612 | 12 SUPPOSITORY in 1 BOX (0713-0536-12) | 12 suppository | 2004-02-28 | 0000-00-00 | No | No | Current |