Norepinephrine Bitartrate
- Product NDC
- 51991-983
- 11-digit product format
- 519910983
- Labeler code
- 51991
- Product ID
- 51991-983_bac5480c-f2a5-4e8a-85f7-a55a059d7c1b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norepinephrine Bitartrate
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Breckenridge Pharmaceutical, Inc.
- Application
- ANDA214455
- Marketing category
- ANDA
- Marketing start
- 2021-07-01
- 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 |
|---|
| 51991-983-17 | Norepinephrine Bitartrate | 10 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 10 | | 3 |
| 51991-983-99 | Norepinephrine Bitartrate | 4 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION, CONCENTRATE | 4 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51991-983 | NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION, CONCENTRATE [BRECKENRIDGE PHARMACEUTICAL, INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240327_109aa5e6-4e42-4131-97b0-f24d3a4cb4e8.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 |
|---|
| 51991-983-17 | 51991098317 | 10 VIAL, SINGLE-DOSE in 1 CARTON (51991-983-17) / 4 mL in 1 VIAL, SINGLE-DOSE (51991-983-99) | | 2021-07-01 | 0000-00-00 | No | No | Current |
| 51991-983-99 | 51991098399 | 4 mL in 1 VIAL, SINGLE-DOSE | 4 ml | | | | | Historical |