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United States · US · US:63629-8886_be9a4264-2327-4dcb-b370-3f9ae9ede6ae

Hydrocodone Bitartrate and Acetaminophen

In shortageOrange BookUNIISPLATC N02BE

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    6362988861
    30 TABLET in 1 BOTTLE (63629-8886-1)
  • ndc11
    6362988862
    20 TABLET in 1 BOTTLE (63629-8886-2)
  • ndc11
    6362988863
    60 TABLET in 1 BOTTLE (63629-8886-3)
  • ndc11
    6362988864
    90 TABLET in 1 BOTTLE (63629-8886-4)
  • ndc11
    6362988865
    120 TABLET in 1 BOTTLE (63629-8886-5)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A210211
AAAAAA
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Acetaminophen; Oxycodone Hydrochloride Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "362O9ITL9D",
    "rxcui": "161",
    "inchikey": "RZVAJINKPMORJF-UHFFFAOYSA-N",
    "display_name": "ACETAMINOPHEN",
    "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": "63629-8886_be9a4264-2327-4dcb-b370-3f9ae9ede6ae",
  "productndc": "63629-8886",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "210211",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;5MG",
        "product_no": "001",
        "approval_date": "Oct 30, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;7.5MG",
        "product_no": "002",
        "approval_date": "Oct 30, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;10MG",
        "product_no": "003",
        "approval_date": "Oct 30, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Hydrocodone Bitartrate and Acetaminophen",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA210211",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydrocodone Bitartrate and Acetaminophen",
  "start_marketing_date": "20180713",
  "active_numerator_strength": "325; 10"
}

Related drugs

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