NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE
- Product NDC
- 44567-643
- 11-digit product format
- 445670643
- Labeler code
- 44567
- Product ID
- 44567-643_a0cf3162-9ed3-4774-a076-fc8af5bbe3d0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NOREPINEPHRINE BITARTRATE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- WG Critical Care, LLC
- Application
- NDA215700
- Marketing category
- NDA
- Marketing start
- 2022-09-15
- Substance
- NOREPINEPHRINE BITARTRATE
- Active strength
- .128 mg/mL
- Pharmacologic classes
- Catecholamine [EPC], Catecholamines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NOREPINEPHRINE BITARTRATE | .128 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | IFY5PE3ZRW |
| Rxcui | 2475337, 2475340, 2619579, 2725614 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 2ab36713-99a4-1d04-c42f-907afc73b6f9 | Product name | 7 | 20260105 |
| 209a4db0-2639-413d-9ad3-274ad7be11f7 | Product name | 1 | 20230912 |
| 08ddeef6-6d79-428b-a00b-432b50fc2b32 | Product name | 1 | 20230831 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 44567-643-01 | NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE | 250 mL in 1 BAG | INJECTION, SOLUTION | 250 | 10 | |
| 44567-643-10 | NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 44567-643-01 | ML - Milliliter | 44567-643 | 3f7e32ea-dc95-48f7-8f3c-9be3cbe2e6b0 | 1 | 2025-12-16 |
| 44567-643-10 | ML - Milliliter | 44567-643 | a6bab38d-9fae-457e-8793-cc0b842f16a9 | 1 | 2025-12-16 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2619579 | norepinephrine bitartrate 16 MG in 250 ML Injection | PSN | ddbef60d-c20a-4ada-928f-e87074c08a54 | 10 |
| 2725614 | norepinephrine bitartrate 32 MG in 250 ML Injection | PSN | ddbef60d-c20a-4ada-928f-e87074c08a54 | 10 |
| 2475337 | norepinephrine bitartrate 4 MG in 250 ML Injection | PSN | ddbef60d-c20a-4ada-928f-e87074c08a54 | 10 |
| 2475340 | norepinephrine bitartrate 8 MG in 250 ML Injection | PSN | ddbef60d-c20a-4ada-928f-e87074c08a54 | 10 |
| 2475337 | 250 ML norepinephrine 0.016 MG/ML Injection | SCD | ddbef60d-c20a-4ada-928f-e87074c08a54 | 10 |
| 2475340 | 250 ML norepinephrine 0.032 MG/ML Injection | SCD | ddbef60d-c20a-4ada-928f-e87074c08a54 | 10 |
| 2619579 | 250 ML norepinephrine 0.064 MG/ML Injection | SCD | ddbef60d-c20a-4ada-928f-e87074c08a54 | 10 |
| 2725614 | 250 ML norepinephrine 0.128 MG/ML Injection | SCD | ddbef60d-c20a-4ada-928f-e87074c08a54 | 10 |
| 2619579 | norepinephrine (as bitartrate) 16 MG per 250 ML Injection | SY | ddbef60d-c20a-4ada-928f-e87074c08a54 | 10 |
| 2725614 | norepinephrine (as bitartrate) 32 MG per 250 ML Injection | SY | ddbef60d-c20a-4ada-928f-e87074c08a54 | 10 |
| 2475337 | norepinephrine (as bitartrate) 4 MG per 250 ML Injection | SY | ddbef60d-c20a-4ada-928f-e87074c08a54 | 10 |
| 2475340 | norepinephrine (as bitartrate) 8 MG per 250 ML Injection | SY | ddbef60d-c20a-4ada-928f-e87074c08a54 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 44567-643-01 | 44567064301 | 250 mL in 1 BAG | 250 ml | Historical | |||
| 44567-643-10 | 44567064310 | 10 BAG in 1 CARTON (44567-643-10) / 250 mL in 1 BAG (44567-643-01) | 10 bag | 2025-10-01 | No | No | Current |