Hydrocodone Bitartrate and Ibuprofen

Orange BookUNIISPLATC R05DA

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

Identification

ManufacturerAmneal Pharmaceuticals of New York LLC

CountryUS (United States)

ATC codeR05DA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5374611601
100 TABLET in 1 BOTTLE (53746-116-01)

Annotations

UNII (FDA Substance ID)

NO70W886KK

HYDROCODONE BITARTRATE

RxCUI 142439

Orange Book

A076642

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "NO70W886KK",
    "rxcui": "142439",
    "inchikey": "JMBRWJAVUIITGV-LNNMZZBZSA-N",
    "display_name": "HYDROCODONE BITARTRATE",
    "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": "53746-116_e109d65b-643b-4c2e-80ad-30c7b3e9c160",
  "productndc": "53746-116",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076642",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG;200MG",
        "product_no": "001",
        "approval_date": "Oct 12, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG;200MG",
        "product_no": "002",
        "approval_date": "Mar 18, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2.5MG;200MG",
        "product_no": "003",
        "approval_date": "Oct 19, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG;200MG",
        "product_no": "004",
        "approval_date": "Oct 19, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCODONE BITARTRATE; IBUPROFEN",
  "proprietary_name": "Hydrocodone Bitartrate and Ibuprofen",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA076642",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydrocodone Bitartrate and Ibuprofen",
  "start_marketing_date": "20100218",
  "active_numerator_strength": "2.5; 200"
}

Related drugs

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