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United States · US · US:43598-735_0b6d0486-2682-21fe-de0a-72d69a4b32c9

levocetirizine dihydrochloride

Orange BookUNIISPLATC R06AE09

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

Identification

ManufacturerDr. Reddy's Laboratories Inc.
CountryUS (United States)
ATC codeR06AE09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 9

  • ndc11
    4359873504
    1 BOTTLE in 1 CARTON (43598-735-04) / 120 TABLET, COATED in 1 BOTTLE
  • ndc11
    4359873522
    1 BOTTLE in 1 CARTON (43598-735-22) / 55 TABLET, COATED in 1 BOTTLE
  • ndc11
    4359873530
    1 BOTTLE in 1 CARTON (43598-735-30) / 30 TABLET, COATED in 1 BOTTLE
  • ndc11
    4359873535
    1 BOTTLE in 1 CARTON (43598-735-35) / 35 TABLET, COATED in 1 BOTTLE
  • ndc11
    4359873558
    1 BOTTLE in 1 CARTON (43598-735-58) / 10 TABLET, COATED in 1 BOTTLE
  • ndc11
    4359873579
    2 BLISTER PACK in 1 CARTON (43598-735-79) / 5 TABLET, COATED in 1 BLISTER PACK
  • ndc11
    4359873580
    1 BOTTLE in 1 CARTON (43598-735-80) / 80 TABLET, COATED in 1 BOTTLE
  • ndc11
    4359873590
    1 BOTTLE in 1 CARTON (43598-735-90) / 90 TABLET, COATED in 1 BOTTLE
  • ndc11
    4359873595
    2 BOTTLE in 1 CARTON (43598-735-95) / 200 TABLET, COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
SOD6A38AGA
LEVOCETIRIZINE DIHYDROCHLORIDE
RxCUI 402349
Orange Book
A210375
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "SOD6A38AGA",
    "rxcui": "402349",
    "inchikey": "PGLIUCLTXOYQMV-GHVWMZMZSA-N",
    "display_name": "LEVOCETIRIZINE DIHYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "8274ca80-e7d3-4f4f-9901-cc5c589b4fef": {
      "match": "brand_token",
      "title": "LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "102",
      "published_date": "2026-05-25"
    }
  },
  "productid": "43598-735_0b6d0486-2682-21fe-de0a-72d69a4b32c9",
  "productndc": "43598-735",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "210375",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jan 19, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LEVOCETIRIZINE DIHYDROCHLORIDE",
  "proprietary_name": "levocetirizine dihydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210375",
  "marketing_category": "ANDA",
  "nonproprietary_name": "levocetirizine dihydrochloride",
  "start_marketing_date": "20180312",
  "active_numerator_strength": "5"
}

Related drugs

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