Norepinephrine Bitartrate
- Product NDC
- 64980-630
- 11-digit product format
- 649800630
- Labeler code
- 64980
- Product ID
- 64980-630_ab8a1422-3508-4480-964c-dbb6681b1428
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norepinephrine Bitartrate
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA218758
- Marketing category
- ANDA
- Marketing start
- 2024-11-01
- 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 |
|---|
| 64980-630-04 | Norepinephrine Bitartrate | 4 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 4 | | 1 |
| 64980-630-41 | Norepinephrine Bitartrate | 10 in 1 CARTON | INJECTION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64980-630 | NOREPINEPHRINE BITARTRATE INJECTION [RISING PHARMA HOLDINGS, INC.] | 1 | Current NDC, 2 package rows | 20241104_e6669ed6-9ebc-4b2d-9a8c-5e318fbd18b4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 64980-630-04 | 64980063004 | 4 mL in 1 VIAL, SINGLE-DOSE | 4 ml | | | | Historical |
| 64980-630-41 | 64980063041 | 10 VIAL, SINGLE-DOSE in 1 CARTON (64980-630-41) / 4 mL in 1 VIAL, SINGLE-DOSE (64980-630-04) | | 2024-11-01 | No | No | Historical |