Promethazine Hydrochloride
- Product NDC
- 50090-4813
- 11-digit product format
- 500904813
- Labeler code
- 50090
- Product ID
- 50090-4813_4639fbda-1925-4364-a4b2-75605a688fcf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA040596
- Marketing category
- ANDA
- Marketing start
- 2005-12-14
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 25 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R61ZEH7I1I |
| Rxcui | 992447 |
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 |
|---|
| 50090-4813-0 | Promethazine Hydrochloride | 12 in 1 BOTTLE | TABLET | 12 | | 8 |
| 50090-4813-1 | Promethazine Hydrochloride | 10 in 1 BOTTLE | TABLET | 10 | | 8 |
| 50090-4813-5 | Promethazine Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 8 |
| 50090-4813-6 | Promethazine Hydrochloride | 20 in 1 BOTTLE | TABLET | 20 | | 8 |
| 50090-4813-9 | Promethazine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-4813 | PROMETHAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS] | 8 | Current NDC, Legacy NDC, 5 package rows | 20241023_6aa6bfcc-024b-4ee2-a586-6c4ca879cea4.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 |
|---|
| 50090-4813-0 | 50090481300 | 12 TABLET in 1 BOTTLE (50090-4813-0) | 12 tablet | 2019-12-27 | 0000-00-00 | No | No | Current |
| 50090-4813-1 | 50090481301 | 10 TABLET in 1 BOTTLE (50090-4813-1) | 10 tablet | 2019-12-27 | 0000-00-00 | No | No | Current |
| 50090-4813-5 | 50090481305 | 60 TABLET in 1 BOTTLE (50090-4813-5) | 60 tablet | 2019-12-27 | 0000-00-00 | No | No | Current |
| 50090-4813-6 | 50090481306 | 20 TABLET in 1 BOTTLE (50090-4813-6) | 20 tablet | 2019-12-27 | 0000-00-00 | No | No | Current |
| 50090-4813-9 | 50090481309 | 30 TABLET in 1 BOTTLE (50090-4813-9) | 30 tablet | 2019-12-27 | 0000-00-00 | No | No | Current |