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United States · US · US:13107-004_ef408ee9-6806-423f-9998-53d81cc71b94
Hydrocodone Bitartrate and Ibuprofen
Orange BookUNIISPLATC R05DA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurolife Pharma, LLC
CountryUS (United States)
ATC codeR05DA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc111310700401100 TABLET, FILM COATED in 1 BOTTLE (13107-004-01)
- ndc111310700405500 TABLET, FILM COATED in 1 BOTTLE (13107-004-05)
- ndc11131070041110 TABLET, FILM COATED in 1 BOTTLE (13107-004-11)
- ndc1113107004991000 TABLET, FILM COATED in 1 BOTTLE (13107-004-99)
Annotations
UNII (FDA Substance ID)
NO70W886KK
HYDROCODONE BITARTRATE
RxCUI 142439
Orange Book
A204575
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "NO70W886KK",
"rxcui": "142439",
"inchikey": "JMBRWJAVUIITGV-LNNMZZBZSA-N",
"display_name": "HYDROCODONE BITARTRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"1f9c1adc-f84f-43de-af5c-d93703aba7f8": {
"match": "brand_token",
"title": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RHODES PHARMACEUTICALS LLC]",
"spl_version": "20",
"published_date": "2026-06-01"
}
},
"productid": "13107-004_ef408ee9-6806-423f-9998-53d81cc71b94",
"productndc": "13107-004",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "204575",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "7.5MG;200MG",
"product_no": "001",
"approval_date": "Jun 2, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": "CII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDROCODONE BITARTRATE; IBUPROFEN",
"proprietary_name": "Hydrocodone Bitartrate and Ibuprofen",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA204575",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydrocodone Bitartrate and Ibuprofen",
"start_marketing_date": "20160602",
"active_numerator_strength": "7.5; 200"
}Related drugs
Other records sharing ATC code R05DA.
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