Promethazine Hydrochloride
- Product NDC
- 68788-7886
- 11-digit product format
- 687887886
- Labeler code
- 68788
- Product ID
- 68788-7886_5c684bfa-9a87-4298-a8f3-407c841a764f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA040596
- Marketing category
- ANDA
- Marketing start
- 2021-04-16
- 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 |
|---|
| 68788-7886-1 | Promethazine Hydrochloride | 10 in 1 BOTTLE | TABLET | 10 | | 5 |
| 68788-7886-2 | Promethazine Hydrochloride | 20 in 1 BOTTLE | TABLET | 20 | | 5 |
| 68788-7886-3 | Promethazine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 68788-7886-8 | Promethazine Hydrochloride | 12 in 1 BOTTLE | TABLET | 12 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-7886 | PROMETHAZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.] | 4 | Current NDC, Legacy NDC, 4 package rows | 20240805_974208c8-4aad-4fb9-991b-cf3085034272.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 |
|---|
| 68788-7886-1 | 68788788601 | 10 TABLET in 1 BOTTLE (68788-7886-1) | 10 tablet | 2021-04-16 | 0000-00-00 | No | No | Current |
| 68788-7886-2 | 68788788602 | 20 TABLET in 1 BOTTLE (68788-7886-2) | 20 tablet | 2021-04-16 | 0000-00-00 | No | No | Current |
| 68788-7886-3 | 68788788603 | 30 TABLET in 1 BOTTLE (68788-7886-3) | 30 tablet | 2021-04-16 | 0000-00-00 | No | No | Current |
| 68788-7886-8 | 68788788608 | 12 TABLET in 1 BOTTLE (68788-7886-8) | 12 tablet | 2021-04-16 | 0000-00-00 | No | No | Current |