Promethazine Hydrochloride
- Product NDC
- 51672-5297
- 11-digit product format
- 516725297
- Labeler code
- 51672
- Product ID
- 51672-5297_03f5c25b-a1d6-496d-8231-4100c5bcdbe4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Labeler
- Taro Pharmaceuticals U.S.A., Inc.
- Application
- ANDA040428
- Marketing category
- ANDA
- Marketing start
- 2015-06-01
- Marketing end
- 0000-00-00
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 25 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 Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51672-5297-1 | Promethazine Hydrochloride | 12 in 1 CARTON | SUPPOSITORY | 12 | | 3 |
| 51672-5297-1 | Promethazine Hydrochloride | 1 in 1 BLISTER PACK | SUPPOSITORY | 1 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Promethazine Hydrochloride | ACTIVE INGREDIENT | R61ZEH7I1I | PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | |
| Promethazine | ACTIVE MOIETY | FF28EJQ494 | PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | |
| ascorbyl palmitate | INACTIVE INGREDIENT | QN83US2B0N | PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | |
| fat, hard | INACTIVE INGREDIENT | 8334LX7S21 | PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | |
| glyceryl monostearate | INACTIVE INGREDIENT | 230OU9XXE4 | PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | |
| white wax | INACTIVE INGREDIENT | 7G1J5DA97F | PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51672-5297 | PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | Legacy NDC, 2 package rows | 20191220_1240d030-9856-4a92-976a-d443507c743a.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 |
|---|
| 51672-5297-1 | 51672529701 | 12 BLISTER PACK in 1 CARTON (51672-5297-1) > 1 SUPPOSITORY in 1 BLISTER PACK | 12 blister pack | 2015-06-01 | 0000-00-00 | No | No | Current |