Promethazine Hydrochloride
- Product NDC
- 50090-4812
- 11-digit product format
- 500904812
- Labeler code
- 50090
- Product ID
- 50090-4812_539f36e4-e67b-4d3f-98a4-cf307f22e42a
- 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 |
|---|
| 50090-4812-0 | Promethazine Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-4812 | PROMETHAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS] | 6 | Current NDC, Legacy NDC, 1 package rows | 20230208_87429921-00d2-42c7-9e99-600e8075b8ce.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 |
|---|
| 50090-4812-0 | 50090481200 | 90 TABLET in 1 BOTTLE (50090-4812-0) | 90 tablet | 2019-12-27 | 0000-00-00 | No | No | Current |