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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

  • ndc11
    4003211803
    30 TABLET in 1 BOTTLE (40032-118-03)
  • ndc11
    4003211824
    100 TABLET in 1 BOTTLE (40032-118-24)
  • ndc11
    4003211826
    500 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.

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