Promethazine Hydrochloride
- Product NDC
- 42254-045
- 11-digit product format
- 422540045
- Labeler code
- 42254
- Product ID
- 42254-045_749af379-2de0-4644-ae06-e8b03d863582
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA091179
- Marketing category
- ANDA
- Marketing start
- 2011-03-03
- 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#
| 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 |
|---|---|---|---|---|---|
| 42254-045-10 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3e1b-c013-e053-90daa90a1393 | PROMETHAZINE HYDROCHLORIDE TABLETS, USP |
| 42254-045-15 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3e1b-c013-e053-90daa90a1393 | PROMETHAZINE HYDROCHLORIDE TABLETS, USP |
| 42254-045-20 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3e1b-c013-e053-90daa90a1393 | PROMETHAZINE HYDROCHLORIDE TABLETS, USP |
| 42254-045-30 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3e1b-c013-e053-90daa90a1393 | PROMETHAZINE HYDROCHLORIDE TABLETS, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42254-045-10 | Promethazine Hydrochloride | 10 in 1 BOTTLE | TABLET | 10 | 1 | |
| 42254-045-15 | Promethazine Hydrochloride | 15 in 1 BOTTLE | TABLET | 15 | 1 | |
| 42254-045-20 | Promethazine Hydrochloride | 20 in 1 BOTTLE | TABLET | 20 | 1 | |
| 42254-045-30 | Promethazine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42254-045-10 | EA - Each | 42254-045 | 3f35e080-a73f-4a90-b3d5-dcb6fc68eefd | 1 | 2012-07-24 |
| 42254-045-15 | EA - Each | 42254-045 | 3937ec1c-3a51-4147-9d9d-b5afc5e79bbe | 1 | 2012-07-24 |
| 42254-045-20 | EA - Each | 42254-045 | 2d0dbac0-a7e1-4df4-bfa2-aa63581c5985 | 1 | 2012-07-24 |
| 42254-045-30 | EA - Each | 42254-045 | 7eb74661-27aa-4ce9-8c09-cc9eedb2fd73 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE | ACTIVE INGREDIENT | R61ZEH7I1I | PROMETHAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| PROMETHAZINE | ACTIVE MOIETY | FF28EJQ494 | PROMETHAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PROMETHAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | PROMETHAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PROMETHAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 992447 | promethazine HCl 25 MG Oral Tablet | PSN | 749af379-2de0-4644-ae06-e8b03d863582 | 1 |
| 992447 | promethazine hydrochloride 25 MG Oral Tablet | SCD | 749af379-2de0-4644-ae06-e8b03d863582 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 42254-045-10 | 42254004510 | 10 in 1 BOTTLE | Historical |
| 42254-045-15 | 42254004515 | 15 in 1 BOTTLE | Historical |
| 42254-045-20 | 42254004520 | 20 in 1 BOTTLE | Historical |
| 42254-045-30 | 42254004530 | 30 in 1 BOTTLE | Historical |