Promethazine Hydrochloride
- Product NDC
- 65162-678
- 11-digit product format
- 651620678
- Labeler code
- 65162
- Product ID
- 65162-678_b501b0a4-d58d-4bf6-8ae1-5a7dae00dcad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA040882
- Marketing category
- ANDA
- Marketing start
- 2009-12-30
- Marketing end
- 0000-00-00
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 6 mg/5mL
- Pharmacologic classes
- Phenothiazine [EPC], Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PROMETHAZINE HYDROCHLORIDE | ACTIVE INGREDIENT | R61ZEH7I1I | PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| PROMETHAZINE | ACTIVE MOIETY | FF28EJQ494 | PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-678 | PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) SOLUTION [AMNEAL PHARMACEUTICALS LLC] | 12 | Legacy NDC | 20241031_afb16e94-03bf-4ea2-b2fe-e65f274e55a9.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65162-678-86 | 65162067886 | 118 mL in 1 BOTTLE (65162-678-86) | 118 ml | 2009-12-30 | 0000-00-00 | No | No | Current |
| 65162-678-90 | 65162067890 | 473 mL in 1 BOTTLE (65162-678-90) | 473 ml | 2009-12-30 | 0000-00-00 | No | No | Current |