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United States · US · US:11822-0050_4b815346-969e-4f5a-af95-09d3c984b36c

ibuprofen pm

Orange BookUNIISPLATC D04AA

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

Identification

ManufacturerRite Aid Corporation
CountryUS (United States)
ATC codeD04AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    1182200501
    1 BOTTLE in 1 CARTON (11822-0050-1) / 80 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    1182200503
    1 BOTTLE in 1 CARTON (11822-0050-3) / 20 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    1182200505
    1 BOTTLE in 1 CARTON (11822-0050-5) / 120 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
4OD433S209
DIPHENHYDRAMINE CITRATE
RxCUI 82004
Orange Book
A079113
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "4OD433S209",
    "rxcui": "82004",
    "inchikey": "SPCKHVPPRJWQRZ-UHFFFAOYSA-N",
    "display_name": "DIPHENHYDRAMINE CITRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "aeee629b-255c-40d8-8e95-779aec00f723": {
      "match": "brand_token",
      "title": "IBUPROFEN TABLET [NORTHSTAR RX LLC]",
      "spl_version": "1",
      "published_date": "2026-06-02"
    }
  },
  "productid": "11822-0050_4b815346-969e-4f5a-af95-09d3c984b36c",
  "productndc": "11822-0050",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "079113",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "38MG;200MG",
        "product_no": "001",
        "approval_date": "Dec 22, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DIPHENHYDRAMINE CITRATE; IBUPROFEN",
  "proprietary_name": "ibuprofen pm",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA079113",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diphenhydramine Citrate, Ibuprofen",
  "start_marketing_date": "20090319",
  "active_numerator_strength": "38; 200"
}

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