PROMETHAZINE HYDROCHLORIDE
- Product NDC
- 84549-525
- 11-digit product format
- 845490525
- Labeler code
- 84549
- Product ID
- 84549-525_45b09a50-dab1-e83d-e063-6394a90aa813
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PROMETHAZINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- ProPharma Distribution
- 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 |
|---|
| 84549-525-03 | PROMETHAZINE HYDROCHLORIDE | 1 mL in 1 AMPULE | INJECTION, SOLUTION | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 84549-525-03 | 84549052503 | 1 mL in 1 AMPULE (84549-525-03) | 1 ml | 2025-12-11 | No | No | Historical |