Promethazine Hydrochloride
- Product NDC
- 10544-618
- 11-digit product format
- 105440618
- Labeler code
- 10544
- Product ID
- 10544-618_18417b93-cfe9-4f53-86ab-afc912d0d06b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA083426
- Marketing category
- ANDA
- Marketing start
- 2010-05-17
- Marketing end
- 0000-00-00
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Phenothiazine [EPC],Phenothiazines [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10544-618-10 | Promethazine Hydrochloride | 10 in 1 BOTTLE | TABLET | 10 | | 2 |
| 10544-618-20 | Promethazine Hydrochloride | 20 in 1 BOTTLE | TABLET | 20 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PROMETHAZINE HYDROCHLORIDE | ACTIVE INGREDIENT | R61ZEH7I1I | PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| PROMETHAZINE | ACTIVE MOIETY | FF28EJQ494 | PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-618 | PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | Legacy NDC, 2 package rows | 20110429_3cf7f19d-efbc-49eb-a4b6-cfbe45a7286e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-618-10 | 10544061810 | 10 in 1 BOTTLE | Historical |
| 10544-618-20 | 10544061820 | 20 in 1 BOTTLE | Historical |