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
7642087700
1000 TABLET in 1 BOTTLE, PLASTIC (76420-877-00)
ndc11
7642087701
1 TABLET in 1 BOTTLE, PLASTIC (76420-877-01)
ndc11
7642087703
3 TABLET in 1 BOTTLE, PLASTIC (76420-877-03)
ndc11
7642087705
500 TABLET in 1 BOTTLE, PLASTIC (76420-877-05)
ndc11
7642087707
7 TABLET in 1 BOTTLE, PLASTIC (76420-877-07)
ndc11
7642087710
100 TABLET in 1 BOTTLE, PLASTIC (76420-877-10)
ndc11
7642087714
14 TABLET in 1 BOTTLE, PLASTIC (76420-877-14)
ndc11
7642087720
20 TABLET in 1 BOTTLE, PLASTIC (76420-877-20)
ndc11
7642087730
30 TABLET in 1 BOTTLE, PLASTIC (76420-877-30)
ndc11
7642087760
60 TABLET in 1 BOTTLE, PLASTIC (76420-877-60)
ndc11
7642087790
90 TABLET in 1 BOTTLE, PLASTIC (76420-877-90)

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": "76420-877_338382b0-08f4-67b8-e063-6294a90a0da4",
  "productndc": "76420-877",
  "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; 10"
}

Related drugs

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