Promethazine Hydrochloride
- Product NDC
- 21695-649
- 11-digit product format
- 216950649
- Labeler code
- 21695
- Product ID
- 21695-649_3087a1cb-fda5-4115-86b6-1cce480a2f8e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA040500
- Marketing category
- ANDA
- Marketing start
- 2003-06-30
- 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 |
|---|---|---|---|---|---|
| 21695-649-12 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4d6d-48b1-e053-8cdaa90a720a | Promethazine Hydrochloride Suppositories, USP 25 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-649-12 | Promethazine Hydrochloride | 1 in 1 CARTON | SUPPOSITORY | 1 | 1 | |
| 21695-649-12 | Promethazine Hydrochloride | 12 in 1 BLISTER PACK | SUPPOSITORY | 12 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-649-12 | EA - Each | 21695-649 | a6641c89-173a-4189-9a89-0db0b21fe079 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Promethazine Hydrochloride | ACTIVE INGREDIENT | R61ZEH7I1I | PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [REBEL DISTRIBUTORS CORP] | 1 | |
| Promethazine | ACTIVE MOIETY | FF28EJQ494 | PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [REBEL DISTRIBUTORS CORP] | 1 | |
| ASCORBYL PALMITATE | INACTIVE INGREDIENT | QN83US2B0N | PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [REBEL DISTRIBUTORS CORP] | 1 | |
| COCOA BUTTER | INACTIVE INGREDIENT | 512OYT1CRR | PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [REBEL DISTRIBUTORS CORP] | 1 | |
| Silicon Dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [REBEL DISTRIBUTORS CORP] | 1 | |
| WHITE WAX | INACTIVE INGREDIENT | 7G1J5DA97F | PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 992454 | promethazine HCl 25 MG Rectal Suppository | PSN | 3087a1cb-fda5-4115-86b6-1cce480a2f8e | 1 |
| 992454 | promethazine hydrochloride 25 MG Rectal Suppository | SCD | 3087a1cb-fda5-4115-86b6-1cce480a2f8e | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-649-12 | 21695064912 | 1 in 1 CARTON | Historical |