🇺🇸
United States · US · US:0074-3878_c35160ee-d73c-4288-8172-d69d75d52b1d
EMBLAVEO
Orange BookUNIISPLATC J01DF
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAbbVie Inc.
CountryUS (United States)
ATC codeJ01DF
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11007438781010 VIAL, SINGLE-DOSE in 1 CARTON (0074-3878-10) / 12 mL in 1 VIAL, SINGLE-DOSE (0074-3878-01)
Annotations
UNII (FDA Substance ID)
7352665165
AVIBACTAM
RxCUI 1603834
Orange Book
N217906
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "7352665165",
"rxcui": "1603834",
"inchikey": "NDCUAPJVLWFHHB-UHNVWZDZSA-N",
"display_name": "AVIBACTAM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"be1a6c99-d4b3-46d7-9e99-6e5f9fab556a": {
"match": "brand_token",
"title": "EMBLAVEO (AZTREONAM AND AVIBACTAM) POWDER, FOR SOLUTION [ABBVIE INC.]",
"spl_version": "5",
"published_date": "2026-04-17"
}
},
"productid": "0074-3878_c35160ee-d73c-4288-8172-d69d75d52b1d",
"productndc": "0074-3878",
"dosage_form": "POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "217906",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 0.5GM BASE/VIAL;1.5GM/VIAL",
"product_no": "001",
"approval_date": "Feb 7, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AVIBACTAM; AZTREONAM",
"proprietary_name": "EMBLAVEO",
"active_ingred_unit": "mg/mL; mg/mL",
"application_number": "NDA217906",
"marketing_category": "NDA",
"nonproprietary_name": "aztreonam and avibactam",
"start_marketing_date": "20250207",
"active_numerator_strength": "42.3; 127"
}Related drugs
Other records sharing ATC code J01DF.
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- 🇫🇷CAYSTON 75 mg, poudre et solvant pour solution pour inhalation par nébiliseurGILEAD SCIENCES IRELAND UC (IRLANDE)
- PLEmblaveoPfizer Europe MA EEIG
- 🇪🇸EMBLAVEO 1,5 G/0,5 G POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSIONPfizer Europe Ma Eeig
- 🇫🇷EMBLAVEO 1,5 g/0,5 g, poudre pour solution à diluer pour perfusionPFIZER EUROPE MA EEIG (BELGIQUE)
- GBEmblaveo 1.5g/0.5g powder for concentrate for solution for infusion vialsPfizer Ltd
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