🇺🇸
United States · US · US:65145-133_9640013b-5019-476a-a35a-2a08084a2a3b
NOREPINEPHRINE BITARTRATE
Orange BookUNIISPLATC C01CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCaplin Steriles Limited
CountryUS (United States)
ATC codeC01CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11651451331010 VIAL, SINGLE-DOSE in 1 CARTON (65145-133-10) / 4 mL in 1 VIAL, SINGLE-DOSE (65145-133-01)
Annotations
UNII (FDA Substance ID)
IFY5PE3ZRW
NOREPINEPHRINE BITARTRATE
RxCUI 7508
Orange Book
A217575
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": "65145-133_9640013b-5019-476a-a35a-2a08084a2a3b",
"productndc": "65145-133",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "217575",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 1MG BASE/ML",
"product_no": "001",
"approval_date": "Sep 15, 2023"
}
],
"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": "ANDA217575",
"marketing_category": "ANDA",
"nonproprietary_name": "norepinephrine bitartrate",
"start_marketing_date": "20240928",
"active_numerator_strength": "1"
}Related drugs
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