Hydrocodone Bitartrate and Acetaminophen

In shortageOrange BookUNIISPLATC N02BE

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

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC codeN02BE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 11

ndc11
7642087500
1000 TABLET in 1 BOTTLE, PLASTIC (76420-875-00)
ndc11
7642087501
1 TABLET in 1 BOTTLE, PLASTIC (76420-875-01)
ndc11
7642087503
3 TABLET in 1 BOTTLE, PLASTIC (76420-875-03)
ndc11
7642087505
500 TABLET in 1 BOTTLE, PLASTIC (76420-875-05)
ndc11
7642087507
7 TABLET in 1 BOTTLE, PLASTIC (76420-875-07)
ndc11
7642087510
100 TABLET in 1 BOTTLE, PLASTIC (76420-875-10)
ndc11
7642087514
14 TABLET in 1 BOTTLE, PLASTIC (76420-875-14)
ndc11
7642087520
20 TABLET in 1 BOTTLE, PLASTIC (76420-875-20)
ndc11
7642087530
30 TABLET in 1 BOTTLE, PLASTIC (76420-875-30)
ndc11
7642087560
60 TABLET in 1 BOTTLE, PLASTIC (76420-875-60)
ndc11
7642087590
90 TABLET in 1 BOTTLE, PLASTIC (76420-875-90)

Annotations

UNII (FDA Substance ID)

362O9ITL9D

ACETAMINOPHEN

RxCUI 161

Orange Book

A202214

AAAAAAAAAAAA

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": "76420-875_338382b0-08f4-67b8-e063-6294a90a0da4",
  "productndc": "76420-875",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202214",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;5MG",
        "product_no": "001",
        "approval_date": "Mar 27, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;7.5MG",
        "product_no": "002",
        "approval_date": "Mar 27, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;10MG",
        "product_no": "003",
        "approval_date": "Mar 27, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "300MG;5MG",
        "product_no": "004",
        "approval_date": "Mar 15, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "300MG;7.5MG",
        "product_no": "005",
        "approval_date": "Mar 15, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "300MG;10MG",
        "product_no": "006",
        "approval_date": "Mar 15, 2016"
      }
    ],
    "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": "ANDA202214",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydrocodone Bitartrate and Acetaminophen",
  "start_marketing_date": "20141006",
  "active_numerator_strength": "325; 5"
}

Related drugs

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