Promethazine Hydrochloride
- Product NDC
- 67046-1447
- 11-digit product format
- 670461447
- Labeler code
- 67046
- Product ID
- 67046-1447_2d996626-a75c-950a-e063-6394a90a9c24
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA040596
- Marketing category
- ANDA
- Marketing start
- 2025-02-07
- 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
- Promethazine Hydrochloride
- 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 | 992475 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67046-1447-3 | Promethazine Hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67046-1447 | PROMETHAZINE HYDROCHLORIDE TABLET [COUPLER LLC] | 1 | Current NDC, 1 package rows | 20250212_2d996287-9eed-265a-e063-6294a90a6969.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 67046-1447-3 | 67046144703 | 30 TABLET in 1 BLISTER PACK (67046-1447-3) | 30 tablet | 2025-02-07 | No | No | Current |