brimonidine tartrate and timolol maleate

Generic: brimonidine tartrate and timolol maleate

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

Drug Facts

Product Profile

Brand Name brimonidine tartrate and timolol maleate
Generic Name brimonidine tartrate and timolol maleate
Labeler alembic pharmaceuticals limited
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

brimonidine tartrate 2 mg/mL, timolol maleate 5 mg/mL

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-706
Product ID 46708-706_b5d560b6-847e-4f09-b1ef-22e4deb8a206
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215230
Listing Expiration 2026-12-31
Marketing Start 2023-08-25

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] adrenergic beta-antagonists [moa] alpha-adrenergic agonist [epc] beta-adrenergic blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708706
Hyphenated Format 46708-706

Supplemental Identifiers

RxCUI
861635
UNII
4S9CL2DY2H P8Y54F701R

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 and timolol maleate (source: ndc)
Generic Name brimonidine tartrate and timolol maleate (source: ndc)
Application Number ANDA215230 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (3)

46708-706-05 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER 46708-706-10 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER 46708-706-15 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER

Ingredients (2)

brimonidine tartrate (2 mg/mL) timolol maleate (5 mg/mL)

Linked Drug Pages (1)

Brimonidine Tartrate and Timolol Maleate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "b5d560b6-847e-4f09-b1ef-22e4deb8a206", "openfda": {"unii": ["4S9CL2DY2H", "P8Y54F701R"], "rxcui": ["861635"], "spl_set_id": ["b5d560b6-847e-4f09-b1ef-22e4deb8a206"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (46708-706-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "46708-706-05", "marketing_start_date": "20230825"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (46708-706-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "46708-706-10", "marketing_start_date": "20230825"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (46708-706-15)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "46708-706-15", "marketing_start_date": "20230825"}], "brand_name": "Brimonidine Tartrate and Timolol Maleate", "product_id": "46708-706_b5d560b6-847e-4f09-b1ef-22e4deb8a206", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Adrenergic beta-Antagonists [MoA]", "alpha-Adrenergic Agonist [EPC]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "46708-706", "generic_name": "Brimonidine Tartrate and Timolol Maleate", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Brimonidine Tartrate and Timolol Maleate", "active_ingredients": [{"name": "BRIMONIDINE TARTRATE", "strength": "2 mg/mL"}, {"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "ANDA215230", "marketing_category": "ANDA", "marketing_start_date": "20230825", "listing_expiration_date": "20261231"}