Norepinephrine Bitartrate
- Product NDC
- 65219-140
- 11-digit product format
- 652190140
- Labeler code
- 65219
- Product ID
- 65219-140_6ccb3099-bd2e-44f5-9585-031ab620e640
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NOREPINEPHRINE BITARTRATE
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA211382
- Marketing category
- ANDA
- Marketing start
- 2021-03-01
- 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 |
|---|
| 65219-140-02 | Norepinephrine Bitartrate | 4 mL in 1 VIAL, SINGLE-DOSE | SOLUTION | 4 | | 1 |
| 65219-140-04 | Norepinephrine Bitartrate | 10 in 1 CARTON | SOLUTION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65219-140 | NOREPINEPHRINE BITARTRATE SOLUTION [FRESENIUS KABI USA, LLC] | 1 | Current NDC, 2 package rows | 20230608_dfed53ef-2060-44b8-a62e-9f8ee10a05a5.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 |
|---|
| 65219-140-02 | 65219014002 | 4 mL in 1 VIAL, SINGLE-DOSE | 4 ml | | | | Historical |
| 65219-140-04 | 65219014004 | 10 VIAL, SINGLE-DOSE in 1 CARTON (65219-140-04) / 4 mL in 1 VIAL, SINGLE-DOSE (65219-140-02) | | 2021-03-01 | No | No | Historical |