brimonidine tartrate ophthalmic solution, 0.15%

Generic: brimonidine tartrate ophthalmic solution, 0.15%

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name brimonidine tartrate ophthalmic solution, 0.15%
Generic Name brimonidine tartrate ophthalmic solution, 0.15%
Labeler alembic pharmaceuticals limited
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

brimonidine tartrate 1.5 mg/mL

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-661
Product ID 46708-661_e1ea003e-3dd9-41c7-9119-d1f209b9820b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215225
Listing Expiration 2026-12-31
Marketing Start 2023-03-29

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] alpha-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708661
Hyphenated Format 46708-661

Supplemental Identifiers

RxCUI
861208
UNII
4S9CL2DY2H

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name brimonidine tartrate ophthalmic solution, 0.15% (source: ndc)
Generic Name brimonidine tartrate ophthalmic solution, 0.15% (source: ndc)
Application Number ANDA215225 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (46708-661-05) / 5 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (46708-661-10) / 10 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (46708-661-15) / 15 mL in 1 BOTTLE
source: ndc

Packages (3)

46708-661-05 1 BOTTLE in 1 CARTON (46708-661-05) / 5 mL in 1 BOTTLE 46708-661-10 1 BOTTLE in 1 CARTON (46708-661-10) / 10 mL in 1 BOTTLE 46708-661-15 1 BOTTLE in 1 CARTON (46708-661-15) / 15 mL in 1 BOTTLE

Ingredients (1)

brimonidine tartrate (1.5 mg/mL)

Linked Drug Pages (1)

Brimonidine Tartrate ophthalmic solution, 0.15% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "e1ea003e-3dd9-41c7-9119-d1f209b9820b", "openfda": {"unii": ["4S9CL2DY2H"], "rxcui": ["861208"], "spl_set_id": ["e1ea003e-3dd9-41c7-9119-d1f209b9820b"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (46708-661-05)  / 5 mL in 1 BOTTLE", "package_ndc": "46708-661-05", "marketing_start_date": "20230329"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (46708-661-10)  / 10 mL in 1 BOTTLE", "package_ndc": "46708-661-10", "marketing_start_date": "20230329"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (46708-661-15)  / 15 mL in 1 BOTTLE", "package_ndc": "46708-661-15", "marketing_start_date": "20230329"}], "brand_name": "Brimonidine Tartrate ophthalmic solution, 0.15%", "product_id": "46708-661_e1ea003e-3dd9-41c7-9119-d1f209b9820b", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "46708-661", "generic_name": "Brimonidine Tartrate ophthalmic solution, 0.15%", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Brimonidine Tartrate ophthalmic solution, 0.15%", "active_ingredients": [{"name": "BRIMONIDINE TARTRATE", "strength": "1.5 mg/mL"}], "application_number": "ANDA215225", "marketing_category": "ANDA", "marketing_start_date": "20230329", "listing_expiration_date": "20261231"}