NOREPINEPHRINE BITARTRATE
- Product NDC
- 83854-017
- 11-digit product format
- 838540017
- Labeler code
- 83854
- Product ID
- 83854-017_44791190-e870-ac45-e063-6294a90acaa9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NOREPINEPHRINE BITARTRATE
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Anthea Pharma Private Limited
- Application
- ANDA219924
- Marketing category
- ANDA
- Marketing start
- 2025-11-25
- Substance
- NOREPINEPHRINE BITARTRATE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Catecholamine [EPC], Catecholamines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NOREPINEPHRINE BITARTRATE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NOREPINEPHRINE BITARTRATE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IFY5PE3ZRW |
| Rxcui | 242969 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83854-017-01 | NOREPINEPHRINE BITARTRATE | 4 mL in 1 VIAL | INJECTION, SOLUTION, CONCENTRATE | 4 | | 3 |
| 83854-017-10 | NOREPINEPHRINE BITARTRATE | 10 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 10 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83854-017-01 | 83854001701 | 4 mL in 1 VIAL | 4 ml | | | | Historical |
| 83854-017-10 | 83854001710 | 10 VIAL in 1 CARTON (83854-017-10) / 4 mL in 1 VIAL (83854-017-01) | 10 vial | 2025-11-25 | No | No | Current |