🇺🇸
United States · US · US:10702-150_526d7f1f-bdeb-5e1f-e063-6294a90a6916
Hydrocodone Bitartrate and Homatropine Methylbromide
In shortageOrange BookUNIISPLATC S01FA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerKVK-Tech, Inc.
CountryUS (United States)
ATC codeS01FA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc111070215016473 mL in 1 BOTTLE (10702-150-16)
Annotations
UNII (FDA Substance ID)
68JRS2HC1C
HOMATROPINE METHYLBROMIDE
RxCUI 27085
Orange Book
A207487
AA
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Homatropine Methylbromide and Hydrocodone Bitartrate Syrup
Raw payload (JSON)
{
"unii": {
"unii": "68JRS2HC1C",
"rxcui": "27085",
"inchikey": "FUFVKLQESJNNAN-RIMUKSHESA-M",
"display_name": "HOMATROPINE METHYLBROMIDE",
"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": "10702-150_526d7f1f-bdeb-5e1f-e063-6294a90a6916",
"productndc": "10702-150",
"dosage_form": "LIQUID",
"orange_book": {
"appl_no": "207487",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "1.5MG/5ML;5MG/5ML",
"product_no": "001",
"approval_date": "Feb 21, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": "CII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE",
"shortage_reason": "Homatropine Methylbromide and Hydrocodone Bitartrate Syrup",
"shortage_status": "current",
"proprietary_name": "Hydrocodone Bitartrate and Homatropine Methylbromide",
"active_ingred_unit": "mg/5mL; mg/5mL",
"application_number": "ANDA207487",
"marketing_category": "ANDA",
"nonproprietary_name": "hydrocodone bitartrate and homatropine methylbromide oral solution",
"start_marketing_date": "20170221",
"active_numerator_strength": "1.5; 5"
}Related drugs
Other records sharing ATC code S01FA.
- 🇺🇸CyclomydrilAlcon Laboratories, Inc.
- 🇺🇸Hydrocodone Bitartrate and Homatropine MethylbromideGenus Lifesciences Inc.
- 🇺🇸Hydrocodone Bitartrate and Homatropine MethylbromideKVK-Tech, Inc.
- 🇺🇸Hydrocodone Bitartrate and Homatropine MethylbromideNovel Laboratories, Inc.
- 🇺🇸Hydrocodone Bitartrate and Homatropine MethylbromideLupin Pharmaceuticals,Inc.
- 🇺🇸Hydrocodone Bitartrate and Homatropine MethylbromideNovel Laboratories, Inc.
- 🇺🇸Hydrocodone Bitartrate and Homatropine MethylbromidePAI Holdings, LLC dba PAI Pharma
- 🇺🇸Hydrocodone Bitartrate and Homatropine MethylbromideGenus Lifesciences Inc.
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