Promethazine Hydrochloride
- Product NDC
- 55045-1643
- 11-digit product format
- 550451643
- Labeler code
- 55045
- Product ID
- 55045-1643_a720b953-0e63-4338-9a7f-ecf7b2784446
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Dispensing Solutions, Inc.
- Application
- ANDA040643
- Marketing category
- ANDA
- Marketing start
- 2006-04-26
- Marketing end
- 0000-00-00
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 6 mg/5mL
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55045-1643-9 | Promethazine Hydrochloride | 118 mL in 1 BOTTLE | SYRUP | 118 | | 1 |
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 Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55045-1643 | PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] | 1 | Legacy NDC, 1 package rows | 20111013_e5be207b-122b-490f-a0d6-841132e45180.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 55045-1643-9 | 55045164309 | 118 mL in 1 BOTTLE | 118 ml | Historical |