Promethazine hydrochloride
- Product NDC
- 21695-453
- 11-digit product format
- 216950453
- Labeler code
- 21695
- Product ID
- 21695-453_23a83c87-ad92-46af-aeed-12e93ab3255d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA083426
- Marketing category
- ANDA
- Marketing start
- 1973-09-19
- 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 |
|---|---|---|---|---|---|
| 21695-453-10 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4980-48b1-e053-8cdaa90a720a | Promethazine Hydrochloride Tablets USP Revised: January 2005 Rx only |
| 21695-453-12 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4980-48b1-e053-8cdaa90a720a | Promethazine Hydrochloride Tablets USP Revised: January 2005 Rx only |
| 21695-453-15 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4980-48b1-e053-8cdaa90a720a | Promethazine Hydrochloride Tablets USP Revised: January 2005 Rx only |
| 21695-453-20 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4980-48b1-e053-8cdaa90a720a | Promethazine Hydrochloride Tablets USP Revised: January 2005 Rx only |
| 21695-453-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4980-48b1-e053-8cdaa90a720a | Promethazine Hydrochloride Tablets USP Revised: January 2005 Rx only |
| 21695-453-60 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4980-48b1-e053-8cdaa90a720a | Promethazine Hydrochloride Tablets USP Revised: January 2005 Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-453-10 | Promethazine hydrochloride | 10 in 1 BOTTLE | TABLET | 10 | 1 | |
| 21695-453-12 | Promethazine hydrochloride | 12 in 1 BOTTLE | TABLET | 12 | 1 | |
| 21695-453-15 | Promethazine hydrochloride | 15 in 1 BOTTLE | TABLET | 15 | 1 | |
| 21695-453-20 | Promethazine hydrochloride | 20 in 1 BOTTLE | TABLET | 20 | 1 | |
| 21695-453-30 | Promethazine hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 21695-453-60 | Promethazine hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-453-10 | EA - Each | 21695-453 | a1aae5f1-221e-4801-9c11-e7d0c653f3f6 | 1 | 2012-07-24 |
| 21695-453-12 | EA - Each | 21695-453 | e3c199c2-d8b4-468a-a715-0c84957b4ff6 | 1 | 2012-07-24 |
| 21695-453-15 | EA - Each | 21695-453 | 50d1ea7d-cf26-4ea9-96f6-924c29143c59 | 1 | 2012-07-24 |
| 21695-453-20 | EA - Each | 21695-453 | 739fe75e-8ec4-45a0-8aa8-8cbc8482e822 | 1 | 2012-07-24 |
| 21695-453-30 | EA - Each | 21695-453 | 77e5b640-d9c3-4e98-8a4f-06e114e7ed3e | 1 | 2012-07-24 |
| 21695-453-60 | EA - Each | 21695-453 | d8a7cbef-5e22-493b-9926-22a5c7a87fde | 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 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | PROMETHAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PROMETHAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PROMETHAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | PROMETHAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| Stearic acid | INACTIVE INGREDIENT | 4ELV7Z65AP | 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 | 23a83c87-ad92-46af-aeed-12e93ab3255d | 1 |
| 992447 | promethazine hydrochloride 25 MG Oral Tablet | SCD | 23a83c87-ad92-46af-aeed-12e93ab3255d | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-453-10 | 21695045310 | 10 in 1 BOTTLE | Historical |
| 21695-453-12 | 21695045312 | 12 in 1 BOTTLE | Historical |
| 21695-453-15 | 21695045315 | 15 in 1 BOTTLE | Historical |
| 21695-453-20 | 21695045320 | 20 in 1 BOTTLE | Historical |
| 21695-453-30 | 21695045330 | 30 in 1 BOTTLE | Historical |
| 21695-453-60 | 21695045360 | 60 in 1 BOTTLE | Historical |