Promethazine Hydrochloride
- Product NDC
- 53217-275
- 11-digit product format
- 532170275
- Labeler code
- 53217
- Product ID
- 53217-275_055186c2-cb5b-4f77-9ef2-aa6a7d2b4c76
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA091179
- Marketing category
- ANDA
- Marketing start
- 2011-03-03
- Marketing end
- 0000-00-00
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 13 mg/1
- Pharmacologic classes
- Phenothiazine [EPC],Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 53217-275-30 | Promethazine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 53217-275-60 | Promethazine Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53217-275 | PROMETHAZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 2 package rows | 20170420_f91688e2-fd64-476f-b9b9-eb4fa4c5bd11.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53217-275-30 | 53217027530 | 30 in 1 BOTTLE | Historical |
| 53217-275-60 | 53217027560 | 60 in 1 BOTTLE | Historical |