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United States · US · US:25021-316_61b38873-cf8d-48b6-b126-2e0a32ac5f7a
Norepinephrine Bitartrate
Orange BookUNIISPLATC C01CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeC01CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11250213160410 VIAL in 1 CARTON (25021-316-04) / 4 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
IFY5PE3ZRW
NOREPINEPHRINE BITARTRATE
RxCUI 7508
Orange Book
A214323
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "IFY5PE3ZRW",
"rxcui": "7508",
"inchikey": "LNBCGLZYLJMGKP-LUDZCAPTSA-N",
"display_name": "NOREPINEPHRINE BITARTRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"ddbef60d-c20a-4ada-928f-e87074c08a54": {
"match": "brand_token",
"title": "NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE (NOREPINEPHRINE BITARTRATE) INJECTION, SOLUTION [WG CRITICAL CARE, LLC]",
"spl_version": "10",
"published_date": "2026-02-18"
}
},
"productid": "25021-316_61b38873-cf8d-48b6-b126-2e0a32ac5f7a",
"productndc": "25021-316",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "214323",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 1MG BASE/ML",
"product_no": "001",
"approval_date": "May 6, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NOREPINEPHRINE BITARTRATE",
"proprietary_name": "Norepinephrine Bitartrate",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA214323",
"marketing_category": "ANDA",
"nonproprietary_name": "Norepinephrine Bitartrate",
"start_marketing_date": "20210701",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code C01CA03.
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- BELevophed 8 mg/4 mlHospira Benelux
- 🇺🇸LEVOPHED(R) NOREPINEPHRINE BITARTRATEHF Acquisition Co LLC, DBA HealthFirst
- BEMivuxin 5 µg/mlLaboratoire Aguettant
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- NOMykronorLaboratoire Aguettant
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