Promethazine Hydrochloride
- Product NDC
- 0603-1584
- 11-digit product format
- 006031584
- Labeler code
- 0603
- Product ID
- 0603-1584_896908f5-e0f2-4ed0-8546-b24a0daef5aa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Par Pharmaceutical
- Application
- ANDA040643
- Marketing category
- ANDA
- Marketing start
- 2006-04-26
- Marketing end
- 2021-05-31
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 6 mg/5mL
- Pharmacologic classes
- Phenothiazine [EPC],Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PROMETHAZINE HYDROCHLORIDE | ACTIVE INGREDIENT | R61ZEH7I1I | PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] | 1 | |
| PROMETHAZINE | ACTIVE MOIETY | FF28EJQ494 | PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] | 1 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] | 1 | |
| CITRIC ACID | INACTIVE INGREDIENT | 2968PHW8QP | PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] | 1 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] | 1 | |
| MENTHOL | INACTIVE INGREDIENT | L7T10EIP3A | PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] | 1 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] | 1 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0603-1584-54 | 00603158454 | 118 mL in 1 BOTTLE (0603-1584-54) | 118 ml | 2006-04-26 | 2021-04-30 | No | No | Current |
| 0603-1584-58 | 00603158458 | 473 mL in 1 BOTTLE (0603-1584-58) | 473 ml | 2006-04-26 | 2021-05-31 | No | No | Current |