Promethazine Hydrochloride
- Product NDC
- 10544-512
- 11-digit product format
- 105440512
- Labeler code
- 10544
- Product ID
- 10544-512_cbbdb28c-bca7-4fc8-827b-1af408e34c05
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA040596
- Marketing category
- ANDA
- Marketing start
- 2010-03-30
- 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 |
|---|---|---|---|---|---|
| 10544-512-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a663-f424-e053-dadaa90a57ce | Promethazine Hydrochloride Tablets USP |
| 10544-512-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a663-f424-e053-dadaa90a57ce | Promethazine Hydrochloride Tablets USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10544-512-10 | Promethazine Hydrochloride | 10 in 1 BOTTLE | TABLET | 10 | 4 | |
| 10544-512-20 | Promethazine Hydrochloride | 20 in 1 BOTTLE | TABLET | 20 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10544-512-10 | EA - Each | 10544-512 | ec990cdf-a134-4b2a-ae2c-71f05efc51a7 | 1 | 2015-10-02 |
| 10544-512-20 | EA - Each | 10544-512 | a6d40869-d7ef-456f-8e41-8cf1cafa958a | 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.] | 4 | |
| PROMETHAZINE | ACTIVE MOIETY | FF28EJQ494 | PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 4 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 4 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 4 |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 10544-512-10 | 10544051210 | 10 in 1 BOTTLE | Historical |
| 10544-512-20 | 10544051220 | 20 in 1 BOTTLE | Historical |