Promethazine Hydrochloride
- Product NDC
- 60687-660
- 11-digit product format
- 606870660
- Labeler code
- 60687
- Product ID
- 60687-660_437eb3f4-c605-1e34-e063-6294a90aba73
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA040596
- Marketing category
- ANDA
- Marketing start
- 2022-06-20
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 12.5 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 | 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 |
|---|
| 60687-660-01 | Promethazine Hydrochloride | 100 in 1 CARTON | TABLET | 100 | | 3 |
| 60687-660-11 | 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 |
|---|
| 60687-660 | PROMETHAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240327_57b4bf23-c563-4357-9dcf-066cbc1280e4.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 |
|---|
| 60687-660-01 | 60687066001 | 100 BLISTER PACK in 1 CARTON (60687-660-01) / 1 TABLET in 1 BLISTER PACK (60687-660-11) | 100 blister pack | 2022-06-20 | 0000-00-00 | No | No | Current |
| 60687-660-11 | 60687066011 | 1 in 1 BLISTER PACK | | | | | | Historical |