Hydrocodone Bitartrate and Homatropine Methylbromide

In shortageOrange BookUNIISPLATC S01FA

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerNovel Laboratories, Inc.

CountryUS (United States)

ATC codeS01FA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4003281005
473 mL in 1 BOTTLE (40032-810-05)

Annotations

UNII (FDA Substance ID)

68JRS2HC1C

HOMATROPINE METHYLBROMIDE

RxCUI 27085

Orange Book

A203535

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": "40032-810_c524711b-29fd-41d1-b026-072e7314b06a",
  "productndc": "40032-810",
  "dosage_form": "SYRUP",
  "orange_book": {
    "appl_no": "203535",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "1.5MG/5ML;5MG/5ML",
        "product_no": "001",
        "approval_date": "Feb 13, 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": "ANDA203535",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydrocodone Bitartrate and Homatropine Methylbromide",
  "start_marketing_date": "20170213",
  "active_numerator_strength": "1.5; 5"
}

Related drugs

Other records sharing ATC code S01FA.

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