Promethazine Hydrochloride
- Product NDC
- 53746-522
- 11-digit product format
- 537460522
- Labeler code
- 53746
- Product ID
- 53746-522_91a3c41d-efc8-4caa-8cec-1976ac46c000
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA091179
- Marketing category
- ANDA
- Marketing start
- 2022-06-22
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Phenothiazine [EPC], Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Promethazine Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PROMETHAZINE HYDROCHLORIDE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R61ZEH7I1I |
| Rxcui | 992438, 992447, 992475 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53746-522-01 | Promethazine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53746-522 | PROMETHAZINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 17 | Current NDC, Legacy NDC, 1 package rows | 20240101_0b5734b8-6a52-44ff-ac29-9a91a4335394.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 |
|---|
| 53746-522-01 | 53746052201 | 100 TABLET in 1 BOTTLE (53746-522-01) | 100 tablet | 2022-06-22 | 0000-00-00 | No | No | Current |