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United States · US · US:21130-056_792e598a-eaee-4d0a-9c99-154ecbf29aaf

Ibuprofen PM

Orange BookUNIISPLATC D04AA

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

Identification

ManufacturerSafeway, Inc.
CountryUS (United States)
ATC codeD04AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    2113005640
    1 BOTTLE, PLASTIC in 1 BOX (21130-056-40) / 40 TABLET, COATED in 1 BOTTLE, PLASTIC
  • ndc11
    2113005680
    1 BOTTLE, PLASTIC in 1 BOX (21130-056-80) / 80 TABLET, COATED in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
4OD433S209
DIPHENHYDRAMINE CITRATE
RxCUI 82004
Orange Book
A211404
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": "21130-056_792e598a-eaee-4d0a-9c99-154ecbf29aaf",
  "productndc": "21130-056",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "211404",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "38MG;200MG",
        "product_no": "001",
        "approval_date": "Apr 11, 2024"
      }
    ],
    "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": "ANDA211404",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diphenhydramine Citrate, Ibuprofen",
  "start_marketing_date": "20240301",
  "active_numerator_strength": "38; 200"
}

Related drugs

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