Promethazine Hydrochloride
- Product NDC
- 68258-3028
- 11-digit product format
- 682583028
- Labeler code
- 68258
- Product ID
- 68258-3028_71576bbf-c1ec-4747-9e44-5b0923c96cbe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Dispensing Solutions Inc.
- Application
- ANDA083312
- Marketing category
- ANDA
- Marketing start
- 2009-05-28
- Marketing end
- 0000-00-00
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 25 mg/mL
- 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 |
|---|
| 68258-3028-1 | Promethazine Hydrochloride | 1 mL in 1 AMPULE | INJECTION, SOLUTION | 1 | | 1 |
| 68258-3028-1 | Promethazine Hydrochloride | 25 in 1 PACKAGE | INJECTION, SOLUTION | 25 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PROMETHAZINE HYDROCHLORIDE | ACTIVE INGREDIENT | R61ZEH7I1I | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.] | 1 | |
| PROMETHAZINE | ACTIVE MOIETY | FF28EJQ494 | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.] | 1 | |
| ACETIC ACID | INACTIVE INGREDIENT | Q40Q9N063P | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.] | 1 | |
| CALCIUM CHLORIDE | INACTIVE INGREDIENT | M4I0D6VV5M | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.] | 1 | |
| PHENOL | INACTIVE INGREDIENT | 339NCG44TV | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.] | 1 | |
| SODIUM ACETATE | INACTIVE INGREDIENT | 4550K0SC9B | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.] | 1 | |
| SODIUM METABISULFITE | INACTIVE INGREDIENT | 4VON5FNS3C | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68258-3028 | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.] | 1 | Legacy NDC, 2 package rows | 20100303_2d846985-d9a2-48ec-be96-31384527b4da.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 68258-3028-1 | 68258302801 | 1 mL in 1 AMPULE | 1 ml | Historical |