Hydrocodone Bitartrate

Orange BookUNIISPLATC R05DA03

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

Identification

ManufacturerAlvogen Inc.

CountryUS (United States)

ATC codeR05DA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4778139860
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-398-60)

Annotations

UNII (FDA Substance ID)

NO70W886KK

HYDROCODONE BITARTRATE

RxCUI 142439

Orange Book

A208269

ABABABABABAB

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": "47781-398_c0f6333c-1d3f-3519-b157-cf817bd5c81d",
  "productndc": "47781-398",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "208269",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Mar 1, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Mar 1, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "003",
        "approval_date": "Mar 1, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "004",
        "approval_date": "Mar 1, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "005",
        "approval_date": "Mar 1, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "006",
        "approval_date": "Mar 1, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "120MG",
        "product_no": "007",
        "approval_date": "Mar 1, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCODONE BITARTRATE",
  "proprietary_name": "Hydrocodone Bitartrate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208269",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydrocodone Bitartrate",
  "start_marketing_date": "20210303",
  "active_numerator_strength": "120"
}

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