PROMETHAZINE HYDROCHLORIDE
- Product NDC
- 39822-5525
- 11-digit product format
- 398225525
- Labeler code
- 39822
- Product ID
- 39822-5525_0e3526e1-38be-1d89-e063-6294a90a775d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PROMETHAZINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- XGen Pharmaceuticals DJB, Inc.
- Application
- ANDA040737
- Marketing category
- ANDA
- Marketing start
- 2015-01-30
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 25 mg/mL
- Pharmacologic classes
- Phenothiazine [EPC], Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PROMETHAZINE HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PROMETHAZINE HYDROCHLORIDE | 25 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R61ZEH7I1I |
| Rxcui | 992460 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 39822-5525-2 | PROMETHAZINE HYDROCHLORIDE | 1 mL in 1 AMPULE | INJECTION, SOLUTION | 1 | | 8 |
| 39822-5525-3 | PROMETHAZINE HYDROCHLORIDE | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PROMETHAZINE HYDROCHLORIDE | ACTIVE INGREDIENT | R61ZEH7I1I | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 2 | |
| PROMETHAZINE | ACTIVE MOIETY | FF28EJQ494 | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 2 | |
| ACETIC ACID | INACTIVE INGREDIENT | Q40Q9N063P | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 2 | |
| CALCIUM CHLORIDE | INACTIVE INGREDIENT | M4I0D6VV5M | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 2 | |
| EDETATE SODIUM | INACTIVE INGREDIENT | MP1J8420LU | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 2 | |
| PHENOL | INACTIVE INGREDIENT | 339NCG44TV | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 2 | |
| SODIUM ACETATE | INACTIVE INGREDIENT | 4550K0SC9B | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 2 | |
| SODIUM METABISULFITE | INACTIVE INGREDIENT | 4VON5FNS3C | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 39822-5525 | PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [XGEN PHARMACEUTICALS DJB, INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240113_1d02d52b-84bb-4e81-b352-125029eb39f6.zip |
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 |
|---|
| 39822-5525-2 | 39822552502 | 1 mL in 1 AMPULE | 1 ml | | | | | Historical |
| 39822-5525-3 | 39822552503 | 25 AMPULE in 1 CARTON (39822-5525-3) / 1 mL in 1 AMPULE (39822-5525-2) | 25 ampule | 2015-01-30 | 0000-00-00 | No | No | Current |