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United States · US · US:10702-055_47ba86ad-2410-e733-e063-6394a90a24e3

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 · 4

  • ndc11
    1070205501
    100 TABLET in 1 BOTTLE (10702-055-01)
  • ndc11
    1070205503
    30 TABLET in 1 BOTTLE (10702-055-03)
  • ndc11
    1070205509
    90 TABLET in 1 BOTTLE (10702-055-09)
  • ndc11
    1070205510
    1000 TABLET in 1 BOTTLE (10702-055-10)

Annotations

UNII (FDA Substance ID)
68JRS2HC1C
HOMATROPINE METHYLBROMIDE
RxCUI 27085
Orange Book
A207176
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": "10702-055_47ba86ad-2410-e733-e063-6394a90a24e3",
  "productndc": "10702-055",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207176",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "1.5MG;5MG",
        "product_no": "001",
        "approval_date": "Aug 7, 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/1; mg/1",
  "application_number": "ANDA207176",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydrocodone Bitartrate and Homatropine Methylbromide",
  "start_marketing_date": "20170807",
  "active_numerator_strength": "1.5; 5"
}

Related drugs

Other records sharing ATC code S01FA.

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