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United States · US · US:53746-145_e109d65b-643b-4c2e-80ad-30c7b3e9c160
Hydrocodone Bitartrate and Ibuprofen
Orange BookUNIISPLATC R05DA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeR05DA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc115374614501100 TABLET in 1 BOTTLE (53746-145-01)
- ndc115374614505500 TABLET in 1 BOTTLE (53746-145-05)
Annotations
UNII (FDA Substance ID)
NO70W886KK
HYDROCODONE BITARTRATE
RxCUI 142439
Orange Book
A076642
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": "53746-145_e109d65b-643b-4c2e-80ad-30c7b3e9c160",
"productndc": "53746-145",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "076642",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "7.5MG;200MG",
"product_no": "001",
"approval_date": "Oct 12, 2004"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG;200MG",
"product_no": "002",
"approval_date": "Mar 18, 2004"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "2.5MG;200MG",
"product_no": "003",
"approval_date": "Oct 19, 2007"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG;200MG",
"product_no": "004",
"approval_date": "Oct 19, 2007"
}
],
"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": "ANDA076642",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydrocodone Bitartrate and Ibuprofen",
"start_marketing_date": "20100218",
"active_numerator_strength": "7.5; 200"
}Related drugs
Other records sharing ATC code R05DA.
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