Promethazine Hydrochloride
- Product NDC
- 51655-758
- 11-digit product format
- 516550758
- Labeler code
- 51655
- Product ID
- 51655-758_49517871-6fe0-374a-e063-6394a90ac136
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA091179
- Marketing category
- ANDA
- Marketing start
- 2023-10-04
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 25 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 | 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 |
|---|
| 51655-758-20 | Promethazine Hydrochloride | 20 in 1 BOTTLE, PLASTIC | TABLET | 20 | | 3 |
| 51655-758-52 | Promethazine Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 3 |
| 51655-758-53 | Promethazine Hydrochloride | 10 in 1 BOTTLE, PLASTIC | TABLET | 10 | | 3 |
| 51655-758-54 | Promethazine Hydrochloride | 15 in 1 BOTTLE, PLASTIC | TABLET | 15 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-758 | PROMETHAZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 2 | Current NDC, 4 package rows | 20240627_075f052e-7f38-7f75-e063-6394a90a512b.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 |
|---|
| 51655-758-20 | 51655075820 | 20 TABLET in 1 BOTTLE, PLASTIC (51655-758-20) | 20 tablet | 2023-10-04 | No | No | Current |
| 51655-758-52 | 51655075852 | 30 TABLET in 1 BOTTLE, PLASTIC (51655-758-52) | 30 tablet | 2024-04-30 | No | No | Current |
| 51655-758-53 | 51655075853 | 10 TABLET in 1 BOTTLE, PLASTIC (51655-758-53) | 10 tablet | 2023-10-12 | No | No | Current |
| 51655-758-54 | 51655075854 | 15 TABLET in 1 BOTTLE, PLASTIC (51655-758-54) | 15 tablet | 2024-01-03 | No | No | Current |