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United States · US · US:72657-157_b3d8d869-735e-4720-8b2b-a3eacc92041f

Acetaminophen, Ibuprofen

In shortageOrange BookUNIISPLATC N02BE

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

Identification

ManufacturerGLENMARK THERAPEUTICS INC., USA
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    7265715705
    1 BOTTLE in 1 CARTON (72657-157-05) / 500 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    7265715718
    1 BOTTLE in 1 CARTON (72657-157-18) / 18 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    7265715720
    1 BOTTLE in 1 CARTON (72657-157-20) / 250 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    7265715736
    1 BOTTLE in 1 CARTON (72657-157-36) / 36 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    7265715772
    1 BOTTLE in 1 CARTON (72657-157-72) / 72 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    7265715774
    1 BOTTLE in 1 CARTON (72657-157-74) / 144 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    7265715776
    1 BOTTLE in 1 CARTON (72657-157-76) / 216 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A218311
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": {
    "353ef34f-760d-ae92-e063-6294a90a5b4a": {
      "match": "brand_token",
      "title": "ACETAMINOPHEN, DEXTROMETHORPHAN HBR ,GUAIFENESIN CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PVT LTD]",
      "spl_version": "5",
      "published_date": "2026-04-28"
    }
  },
  "productid": "72657-157_b3d8d869-735e-4720-8b2b-a3eacc92041f",
  "productndc": "72657-157",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "218311",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "250MG;125MG",
        "product_no": "001",
        "approval_date": "Apr 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, Ibuprofen",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA218311",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acetaminophen, Ibuprofen",
  "start_marketing_date": "20240507",
  "active_numerator_strength": "250; 125"
}

Related drugs

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