PROMETHAZINE HYDROCHLORIDE
- Product NDC
- 43063-875
- 11-digit product format
- 430630875
- Labeler code
- 43063
- Product ID
- 43063-875_526d2e7c-1b0b-b2f7-e063-6294a90ac077
- 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
- 2007-05-04
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 12.5 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 | 12.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R61ZEH7I1I |
| Rxcui | 992438 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-875-01 | PROMETHAZINE HYDROCHLORIDE | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-875 | PROMETHAZINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] | 17 | Current NDC, Legacy NDC, 1 package rows | 20240820_b0ba50da-9f70-4531-a9de-3dd3f8aa1f5d.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 |
|---|
| 43063-875-01 | 43063087501 | 100 TABLET in 1 BOTTLE, PLASTIC (43063-875-01) | 100 tablet | 2018-08-17 | 0000-00-00 | No | No | Current |