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United States · US · US:0023-9211_fa68af94-117a-436f-a3ea-cd0edde443d4

COMBIGAN

Orange BookUNIISPLATC D11AX

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

Identification

ManufacturerAllergan, Inc.
CountryUS (United States)
ATC codeD11AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)
4S9CL2DY2H
BRIMONIDINE TARTRATE
RxCUI 39171
Orange Book
N021398
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "4S9CL2DY2H",
    "rxcui": "39171",
    "inchikey": "QZHBYNSSDLTCRG-LREBCSMRSA-N",
    "display_name": "BRIMONIDINE TARTRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "feaf1480-a4b8-4486-992a-96be3a596243": {
      "match": "brand_token",
      "title": "COMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE) SOLUTION/ DROPS [ALLERGAN, INC.]",
      "spl_version": "22",
      "published_date": "2026-03-30"
    }
  },
  "productid": "0023-9211_fa68af94-117a-436f-a3ea-cd0edde443d4",
  "productndc": "0023-9211",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "021398",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.2%;EQ 0.5% BASE",
        "product_no": "001",
        "approval_date": "Oct 30, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BRIMONIDINE TARTRATE; TIMOLOL MALEATE",
  "proprietary_name": "COMBIGAN",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "NDA021398",
  "marketing_category": "NDA",
  "nonproprietary_name": "brimonidine tartrate, timolol maleate",
  "start_marketing_date": "20071114",
  "active_numerator_strength": "2; 5"
}

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