🇺🇸
United States · US · US:40032-118_ced58732-29db-4f15-a4d4-858f3e4ecc4e
Hydrocodone Bitartrate and Homatropine Methylbromide
In shortageOrange BookUNIISPLATC S01FA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovel Laboratories, Inc.
CountryUS (United States)
ATC codeS01FA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11400321180330 TABLET in 1 BOTTLE (40032-118-03)
- ndc114003211824100 TABLET in 1 BOTTLE (40032-118-24)
- ndc114003211826500 TABLET in 1 BOTTLE (40032-118-26)
Annotations
UNII (FDA Substance ID)
68JRS2HC1C
HOMATROPINE METHYLBROMIDE
RxCUI 27085
Orange Book
A091528
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": "40032-118_ced58732-29db-4f15-a4d4-858f3e4ecc4e",
"productndc": "40032-118",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "091528",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1.5MG;5MG",
"product_no": "001",
"approval_date": "Apr 20, 2011"
}
],
"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/1; mg/1",
"application_number": "ANDA091528",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydrocodone Bitartrate and Homatropine Methylbromide",
"start_marketing_date": "20140923",
"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 MethylbromideKVK-Tech, 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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