Promethazine Hydrochloride
- Product NDC
- 0904-7304
- 11-digit product format
- 009047304
- Labeler code
- 0904
- Product ID
- 0904-7304_483c6903-10ec-4665-9dba-8073728937cf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA091179
- Marketing category
- ANDA
- Marketing start
- 2023-04-17
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Phenothiazine [EPC], Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Promethazine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PROMETHAZINE HYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R61ZEH7I1I |
| Rxcui | 992447 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7304-61 | Promethazine Hydrochloride | 100 in 1 CARTON | TABLET | 100 | | 3 |
| 0904-7304-61 | Promethazine Hydrochloride | 1 in 1 BLISTER PACK | TABLET | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7304 | PROMETHAZINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] | 2 | Current NDC, 2 package rows | 20241030_4cee8622-7d59-4794-8e32-54f7aac1d923.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0904-7304-61 | 00904730461 | 100 BLISTER PACK in 1 CARTON (0904-7304-61) / 1 TABLET in 1 BLISTER PACK | 100 blister pack | 2023-04-17 | No | No | Historical |