NOREPINEPHRINE BITARTRATE
- Product NDC
- 47335-615
- 11-digit product format
- 473350615
- Labeler code
- 47335
- Product ID
- 47335-615_4bb42f07-a41e-42f3-92e7-dab665584f84
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NOREPINEPHRINE BITARTRATE
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA211980
- 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 |
|---|
| 47335-615-44 | NOREPINEPHRINE BITARTRATE | 4 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION, CONCENTRATE | 4 | | 1 |
| 47335-615-44 | NOREPINEPHRINE BITARTRATE | 10 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-615 | NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION, CONCENTRATE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20210701_4bb42f07-a41e-42f3-92e7-dab665584f84.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 47335-615-44 | 47335061544 | 10 VIAL, SINGLE-DOSE in 1 CARTON (47335-615-44) / 4 mL in 1 VIAL, SINGLE-DOSE | 2021-07-01 | 0000-00-00 | No | No | Current |