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United States · US · US:49035-276_3ff5b3ae-c55b-ee05-e063-6294a90ac323

Equate

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerWal-Mart Stores Inc
CountryUS (United States)
ATC codeR06AE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    4903527601
    1 BOTTLE in 1 CARTON (49035-276-01) / 240 mL in 1 BOTTLE
  • ndc11
    4903527602
    1 BOTTLE in 1 CARTON (49035-276-02) / 240 mL in 1 BOTTLE
  • ndc11
    4903527608
    1 BOTTLE in 1 CARTON (49035-276-08) / 120 mL in 1 BOTTLE
  • ndc11
    4903527609
    1 BOTTLE in 1 CARTON (49035-276-09) / 120 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A090182
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "64O047KTOA",
    "rxcui": "203150",
    "inchikey": "PGLIUCLTXOYQMV-UHFFFAOYSA-N",
    "display_name": "CETIRIZINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "2ac53cc7-000f-41fd-b799-4e6d6886fe62": {
      "match": "brand_token",
      "title": "EQUATE DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]",
      "spl_version": "5",
      "published_date": "2026-06-01"
    }
  },
  "productid": "49035-276_3ff5b3ae-c55b-ee05-e063-6294a90ac323",
  "productndc": "49035-276",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "090182",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG/5ML",
        "product_no": "001",
        "approval_date": "Apr 22, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG/5ML",
        "product_no": "002",
        "approval_date": "Apr 22, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "Equate",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA090182",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cetirizine Hydrochloride",
  "start_marketing_date": "20110908",
  "active_numerator_strength": "5"
}

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