Acetaminophen and Ibuprofen

In shortageOrange BookUNIISPLATC N02BE

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

Identification

ManufacturerAurohealth LLC

CountryUS (United States)

ATC codeN02BE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 30

ndc11
5860289301
1 BOTTLE, PLASTIC in 1 CARTON (58602-893-01) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
ndc11
5860289302
1 BOTTLE in 1 CARTON (58602-893-02) / 144 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860289303
1 BOTTLE in 1 CARTON (58602-893-03) / 10 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860289307
1 BOTTLE in 1 CARTON (58602-893-07) / 24 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860289311
1 BOTTLE in 1 CARTON (58602-893-11) / 36 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860289314
1 BOTTLE in 1 CARTON (58602-893-14) / 50 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860289321
1 BOTTLE in 1 CARTON (58602-893-21) / 100 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860289329
1 BOTTLE in 1 CARTON (58602-893-29) / 150 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860289335
225 TABLET, FILM COATED in 1 BOTTLE (58602-893-35)
ndc11
5860289340
500 TABLET, FILM COATED in 1 BOTTLE (58602-893-40)
ndc11
5860289341
1000 TABLET, FILM COATED in 1 BOTTLE (58602-893-41)
ndc11
5860289344
400 TABLET, FILM COATED in 1 BOTTLE (58602-893-44)
ndc11
5860289346
1 BOTTLE, PLASTIC in 1 CARTON (58602-893-46) / 18 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
ndc11
5860289349
1 BOTTLE, PLASTIC in 1 CARTON (58602-893-49) / 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
ndc11
5860289351
216 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-893-51)
ndc11
5860289361
1 BLISTER PACK in 1 CARTON (58602-893-61) / 2 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
5860289362
216 TABLET, FILM COATED in 1 BOTTLE (58602-893-62)
ndc11
5860289365
1 BOTTLE in 1 CARTON (58602-893-65) / 72 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860289373
1 BOTTLE in 1 CARTON (58602-893-73) / 20 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860289378
1 BOTTLE, PLASTIC in 1 CARTON (58602-893-78) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
ndc11
5860289379
500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-893-79)
ndc11
5860289380
1 BOTTLE, PLASTIC in 1 CARTON (58602-893-80) / 72 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
ndc11
5860289382
1 BOTTLE in 1 CARTON (58602-893-82) / 18 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860289384
225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-893-84)
ndc11
5860289385
1 BOTTLE, PLASTIC in 1 CARTON (58602-893-85) / 36 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
ndc11
5860289388
750 TABLET, FILM COATED in 1 BOTTLE (58602-893-88)
ndc11
5860289394
1 BOTTLE, PLASTIC in 1 CARTON (58602-893-94) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
ndc11
5860289395
750 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-893-95)
ndc11
5860289396
1 BOTTLE, PLASTIC in 1 CARTON (58602-893-96) / 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
ndc11
5860289399
400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-893-99)

Annotations

UNII (FDA Substance ID)

362O9ITL9D

ACETAMINOPHEN

RxCUI 161

Orange Book

A218359

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": {
    "44520aa1-b63f-4239-e063-6394a90a5e14": {
      "match": "brand_token",
      "title": "ACETAMINOPHEN LIQUID / ACETAMINOPHEN DIPHENHYDRAMINE HCL LIQUID (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [KROGER]",
      "spl_version": "2",
      "published_date": "2026-06-02"
    }
  },
  "productid": "58602-893_4c479545-4af0-49b7-8a62-632a97c5c637",
  "productndc": "58602-893",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "218359",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "250MG;125MG",
        "product_no": "001",
        "approval_date": "Mar 26, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; IBUPROFEN",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Acetaminophen and Ibuprofen",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA218359",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acetaminophen and Ibuprofen",
  "start_marketing_date": "20240326",
  "active_numerator_strength": "250; 125"
}

Related drugs

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