PROMETHAZINE HYDROCHLORIDE
- Product NDC
- 10544-051
- 11-digit product format
- 105440051
- Labeler code
- 10544
- Product ID
- 10544-051_0f60819b-0015-42fb-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- promethazine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA040712
- Marketing category
- ANDA
- Marketing start
- 2011-08-25
- Marketing end
- 0000-00-00
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 13 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#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3036445d-7d13-4411-a100-f2ac5ab8a276 | Product name | 1 | 20240110 |
| 2e7222fb-e3f1-febd-962f-ddbb495d6b5f | Product name | 2 | 20220126 |
| 09d8330d-4fec-be98-3a66-f985140646b2 | Product name | 2 | 20210513 |
| 4f881de7-085a-407e-abc2-faa3c0127432 | Product name | 1 | 20170811 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
| d51697af-7f97-0559-95d1-fe94f3f031d5 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10544-051-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2c41-f424-e053-dadaa90a57ce | PROMETHAZINE HYDROCHLORIDE TABLETS, USP |
| 10544-051-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2c41-f424-e053-dadaa90a57ce | PROMETHAZINE HYDROCHLORIDE TABLETS, USP |
| 10544-051-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2c41-f424-e053-dadaa90a57ce | PROMETHAZINE HYDROCHLORIDE TABLETS, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10544-051-10 | PROMETHAZINE HYDROCHLORIDE | 10 in 1 BOTTLE | TABLET | 10 | 1 | |
| 10544-051-20 | PROMETHAZINE HYDROCHLORIDE | 20 in 1 BOTTLE | TABLET | 20 | 1 | |
| 10544-051-30 | PROMETHAZINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET | 30 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10544-051-10 | EA - Each | 10544-051 | 8b9276e3-91cc-4f11-8054-ed0c7fe89cad | 1 | 2015-10-02 |
| 10544-051-20 | EA - Each | 10544-051 | 8d92d8eb-96af-4eb8-9295-ab7b3263e60d | 1 | 2015-10-02 |
| 10544-051-30 | EA - Each | 10544-051 | f7317a31-e6cb-4fa9-aff6-0f9aa5703286 | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE | ACTIVE INGREDIENT | R61ZEH7I1I | PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| PROMETHAZINE | ACTIVE MOIETY | FF28EJQ494 | PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| METHYLCELLULOSE (100 CPS) | INACTIVE INGREDIENT | 4GFU244C4J | PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 1 |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 10544-051-10 | 10544005110 | 10 in 1 BOTTLE | Historical |
| 10544-051-20 | 10544005120 | 20 in 1 BOTTLE | Historical |
| 10544-051-30 | 10544005130 | 30 in 1 BOTTLE | Historical |