Back to search
🇺🇸

United States · US · US:46708-706_b5d560b6-847e-4f09-b1ef-22e4deb8a206

Brimonidine Tartrate and Timolol Maleate

Orange BookUNIISPLATC D11AX

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

Identification

ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeD11AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4670870605
    1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER
  • ndc11
    4670870610
    1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER
  • ndc11
    4670870615
    1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
4S9CL2DY2H
BRIMONIDINE TARTRATE
RxCUI 39171
Orange Book
A215230
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": {
    "f6666d85-f810-4869-993d-e8ae35b4517f": {
      "match": "brand_token",
      "title": "BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION SOLUTION/ DROPS [LIFESTAR PHARMA LLC]",
      "spl_version": "5",
      "published_date": "2026-06-02"
    }
  },
  "productid": "46708-706_b5d560b6-847e-4f09-b1ef-22e4deb8a206",
  "productndc": "46708-706",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "215230",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.2%;EQ 0.5% BASE",
        "product_no": "001",
        "approval_date": "Aug 25, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BRIMONIDINE TARTRATE; TIMOLOL MALEATE",
  "proprietary_name": "Brimonidine Tartrate and Timolol Maleate",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "ANDA215230",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Brimonidine Tartrate and Timolol Maleate",
  "start_marketing_date": "20230825",
  "active_numerator_strength": "2; 5"
}

Related drugs

Other records sharing ATC code D11AX.

Access this data programmatically

Query Brimonidine Tartrate and Timolol Maleate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.