promethazine hydrochloride
- Product NDC
- 50090-6431
- 11-digit product format
- 500906431
- Labeler code
- 50090
- Product ID
- 50090-6431_20e7b205-90c4-4ac8-bc30-a55f38a1030d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- promethazine hydrochloride
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA091675
- Marketing category
- ANDA
- Marketing start
- 2012-06-08
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 6.25 mg/5mL
- 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 | 6.25 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R61ZEH7I1I |
| Rxcui | 992432 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-6431-0 | promethazine hydrochloride | 473 mL in 1 BOTTLE | SYRUP | 473 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-6431 | PROMETHAZINE HYDROCHLORIDE SYRUP [A-S MEDICATION SOLUTIONS] | 2 | Current NDC, 1 package rows | 20230911_c0a68671-407b-4840-9662-04f168cff1cb.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 |
|---|
| 50090-6431-0 | 50090643100 | 473 mL in 1 BOTTLE (50090-6431-0) | 473 ml | 2023-04-10 | No | No | Historical |