PROMETHAZINE HYDROCHLORIDE
- Product NDC
- 53002-4020
- 11-digit product format
- 530024020
- Labeler code
- 53002
- Product ID
- 53002-4020_bcc4b9e8-a4f2-4113-8b7c-706bd0ef6269
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- promethazine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA040712
- Marketing category
- ANDA
- Marketing start
- 2006-07-31
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53002-4020-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d1-1461-f424-e053-dadaa90a57ce | PROMETHAZINE HYDROCHLORIDE TABLETS, USP |
| 53002-4020-2 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d1-1461-f424-e053-dadaa90a57ce | PROMETHAZINE HYDROCHLORIDE TABLETS, USP |
| 53002-4020-3 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d1-1461-f424-e053-dadaa90a57ce | PROMETHAZINE HYDROCHLORIDE TABLETS, USP |
| 53002-4020-1 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d1-1461-f424-e053-dadaa90a57ce | PROMETHAZINE HYDROCHLORIDE TABLETS, USP |
| 53002-4020-2 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d1-1461-f424-e053-dadaa90a57ce | PROMETHAZINE HYDROCHLORIDE TABLETS, USP |
| 53002-4020-3 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d1-1461-f424-e053-dadaa90a57ce | PROMETHAZINE HYDROCHLORIDE TABLETS, USP |
| 53002-4020-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1461-f424-e053-dadaa90a57ce | PROMETHAZINE HYDROCHLORIDE TABLETS, USP |
| 53002-4020-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1461-f424-e053-dadaa90a57ce | PROMETHAZINE HYDROCHLORIDE TABLETS, USP |
| 53002-4020-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1461-f424-e053-dadaa90a57ce | PROMETHAZINE HYDROCHLORIDE TABLETS, USP |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-4020-1 | PROMETHAZINE HYDROCHLORIDE | 5 in 1 BOTTLE | TABLET | 5 | | 3 |
| 53002-4020-2 | PROMETHAZINE HYDROCHLORIDE | 10 in 1 BOTTLE | TABLET | 10 | | 3 |
| 53002-4020-3 | PROMETHAZINE HYDROCHLORIDE | 20 in 1 BOTTLE | TABLET | 20 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-4020 | PROMETHAZINE HYDROCHLORIDE TABLET [RPK PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 3 package rows | 20201218_c8b6d06b-1468-4ff5-bf76-813abb5a093f.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 |
|---|
| 53002-4020-1 | 53002402001 | 5 TABLET in 1 BOTTLE (53002-4020-1) | 5 tablet | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-4020-2 | 53002402002 | 10 TABLET in 1 BOTTLE (53002-4020-2) | 10 tablet | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-4020-3 | 53002402003 | 20 TABLET in 1 BOTTLE (53002-4020-3) | 20 tablet | 2018-10-01 | 0000-00-00 | No | No | Current |