Promethazine Hydrochloride
- Product NDC
- 53002-4021
- 11-digit product format
- 530024021
- Labeler code
- 53002
- Product ID
- 53002-4021_e91858f4-0c92-451b-8824-032a87d79d1d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA040596
- Marketing category
- ANDA
- Marketing start
- 2005-12-14
- Marketing end
- 0000-00-00
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Phenothiazine [EPC], Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|
| 53002-4021-1 | Promethazine Hydrochloride | 5 in 1 BOTTLE | TABLET | 5 | | 1 |
| 53002-4021-2 | Promethazine Hydrochloride | 10 in 1 BOTTLE | TABLET | 10 | | 1 |
| 53002-4021-3 | Promethazine Hydrochloride | 20 in 1 BOTTLE | TABLET | 20 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-4021 | PROMETHAZINE HYDROCHLORIDE TABLET [RPK PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 3 package rows | 20220331_8d952b80-84c0-409a-901f-cb26818022b8.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 |
|---|
| 53002-4021-1 | 53002402101 | 5 TABLET in 1 BOTTLE (53002-4021-1) | 5 tablet | 2022-11-01 | 0000-00-00 | No | No | Current |
| 53002-4021-2 | 53002402102 | 10 TABLET in 1 BOTTLE (53002-4021-2) | 10 tablet | 2022-11-01 | 0000-00-00 | No | No | Current |
| 53002-4021-3 | 53002402103 | 20 TABLET in 1 BOTTLE (53002-4021-3) | 20 tablet | 2022-11-01 | 0000-00-00 | No | No | Current |