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United States · US · US:0023-3615_8ecbdc67-bc68-4437-b99d-9924e25dfe67

ZYMAXID

Orange BookUNIISPLATC S01AE06

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

Identification

ManufacturerAllergan, Inc.
CountryUS (United States)
ATC codeS01AE06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0023361501
    1 BOTTLE, DROPPER in 1 CARTON (0023-3615-01) / 1 mL in 1 BOTTLE, DROPPER
  • ndc11
    0023361525
    1 BOTTLE, DROPPER in 1 CARTON (0023-3615-25) / 2.5 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
L4618BD7KJ
GATIFLOXACIN
RxCUI 228476
Orange Book
N022548
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "L4618BD7KJ",
    "rxcui": "228476",
    "inchikey": "RMJMZKDEVNTXHE-UHFFFAOYSA-N",
    "display_name": "GATIFLOXACIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "1160b16c-929a-4e85-9c0b-1d8c96a7678b": {
      "match": "brand_token",
      "title": "ZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.]",
      "spl_version": "11",
      "published_date": "2024-11-22"
    }
  },
  "productid": "0023-3615_8ecbdc67-bc68-4437-b99d-9924e25dfe67",
  "productndc": "0023-3615",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "022548",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "0.5%",
        "product_no": "001",
        "approval_date": "May 18, 2010"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GATIFLOXACIN",
  "proprietary_name": "ZYMAXID",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA022548",
  "marketing_category": "NDA",
  "nonproprietary_name": "gatifloxacin",
  "start_marketing_date": "20100519",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code S01AE06.

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