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United States · US · US:0003-2570_1308cf65-8900-4fc3-8a41-47b766adbd3a
AZACTAM
Orange BookUNIISPLATC J01DF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerE.R. Squibb & Sons, L.L.C.
CountryUS (United States)
ATC codeJ01DF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11000325701610 VIAL, SINGLE-DOSE in 1 CARTON (0003-2570-16) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
G2B4VE5GH8
AZTREONAM
RxCUI 1272
Orange Book
N050580
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "G2B4VE5GH8",
"rxcui": "1272",
"inchikey": "WZPBZJONDBGPKJ-VEHQQRBSSA-N",
"display_name": "AZTREONAM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR; INTRAVENOUS",
"spl_meta": {
"9a105eaf-ee77-4016-beeb-d425a5565db2": {
"match": "brand_token",
"title": "AZACTAM (AZTREONAM) INJECTION, POWDER, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.]",
"spl_version": "15",
"published_date": "2025-12-23"
}
},
"productid": "0003-2570_1308cf65-8900-4fc3-8a41-47b766adbd3a",
"productndc": "0003-2570",
"dosage_form": "INJECTION, POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "050580",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "001",
"approval_date": "Dec 31, 1986"
},
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "1GM/VIAL",
"product_no": "002",
"approval_date": "Dec 31, 1986"
},
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "2GM/VIAL",
"product_no": "003",
"approval_date": "Dec 31, 1986"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AZTREONAM",
"proprietary_name": "AZACTAM",
"active_ingred_unit": "g/1",
"application_number": "NDA050580",
"marketing_category": "NDA",
"nonproprietary_name": "AZTREONAM",
"start_marketing_date": "20100401",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code J01DF01.
- NOAzactamLaboratoires Delbert
- FIAzactamLaboratoires Delbert x
- FIAzactamBristol-Myers Squibb GmbH
- 🇺🇸AZACTAMA-S Medication Solutions
- 🇺🇸AZACTAME.R. Squibb & Sons, L.L.C.
- BEAzactam 1 gLaboratoires Delbert
- IEAzactam 1 g Powder for Solution for Injection or InfusionAthlone Pharmaceuticals Limited
- 🇫🇷AZACTAM 1 g, poudre pour solution injectable/pour perfusionLABORATOIRES DELBERT
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