Hydrocodone APAP

In shortageOrange BookUNIISPLATC N02BE

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

Identification

ManufacturerDirect_Rx

CountryUS (United States)

ATC codeN02BE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7218935230
30 TABLET in 1 BOTTLE (72189-352-30)
ndc11
7218935260
60 TABLET in 1 BOTTLE (72189-352-60)
ndc11
7218935272
120 TABLET in 1 BOTTLE (72189-352-72)
ndc11
7218935290
90 TABLET in 1 BOTTLE (72189-352-90)

Annotations

UNII (FDA Substance ID)

362O9ITL9D

ACETAMINOPHEN

RxCUI 161

Orange Book

A211487

AAAAAAAA

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": "72189-352_2cc75c9b-0042-6e35-e063-6394a90adfb5",
  "productndc": "72189-352",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211487",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;2.5MG",
        "product_no": "001",
        "approval_date": "Nov 7, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;5MG",
        "product_no": "002",
        "approval_date": "Nov 7, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;7.5MG",
        "product_no": "003",
        "approval_date": "Nov 7, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;10MG",
        "product_no": "004",
        "approval_date": "Nov 7, 2018"
      }
    ],
    "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 APAP",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA211487",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydrocodone APAP",
  "start_marketing_date": "20220510",
  "active_numerator_strength": "325; 7.5"
}

Related drugs

Other records sharing ATC code N02BE.

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