PROMETHAZINE HYDROCHLORIDE
- Product NDC
- 43063-876
- 11-digit product format
- 430630876
- Labeler code
- 43063
- Product ID
- 43063-876_526d1560-af9a-fea1-e063-6394a90af414
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- promethazine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA040712
- Marketing category
- ANDA
- Marketing start
- 2006-07-31
- 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 | 992475 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-876-01 | PROMETHAZINE HYDROCHLORIDE | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 20 |
| 43063-876-04 | PROMETHAZINE HYDROCHLORIDE | 4 in 1 BOTTLE, PLASTIC | TABLET | 4 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-876 | PROMETHAZINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] | 18 | Current NDC, Legacy NDC, 2 package rows | 20241210_f93ca67d-362a-473f-8296-2952da77c074.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 |
|---|
| 43063-876-01 | 43063087601 | 100 TABLET in 1 BOTTLE, PLASTIC (43063-876-01) | 100 tablet | 2018-07-17 | 0000-00-00 | No | No | Current |
| 43063-876-04 | 43063087604 | 4 TABLET in 1 BOTTLE, PLASTIC (43063-876-04) | 4 tablet | 2018-12-07 | 0000-00-00 | No | No | Current |