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United States · US · US:59779-050_606dc577-e485-4e35-afd0-41373c9cb627

ibuprofen pm

Orange BookUNIISPLATC D04AA

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

Identification

ManufacturerCVS Pharmacy
CountryUS (United States)
ATC codeD04AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    5977905027
    1 BOTTLE in 1 CARTON (59779-050-27) / 80 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5977905060
    1 BOTTLE in 1 CARTON (59779-050-60) / 20 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5977905076
    1 BOTTLE in 1 CARTON (59779-050-76) / 120 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5977905082
    200 TABLET, FILM COATED in 1 BOTTLE (59779-050-82)

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": "59779-050_606dc577-e485-4e35-afd0-41373c9cb627",
  "productndc": "59779-050",
  "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 and ibuprofen",
  "start_marketing_date": "20090217",
  "active_numerator_strength": "38; 200"
}

Related drugs

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