Home NDC 81469-291 Bimatoprost
Product NDC 81469-291
11-digit product format 814690291
Labeler code 81469
Product ID 81469-291_ca1226b7-9c73-4105-9eea-9f60ca622f71
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bimatoprost
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler First Nation Group, LLC
Application ANDA218196
Marketing category ANDA
Marketing start 2026-05-01
Substance BIMATOPROST
Active strength .1 mg/mL
Pharmacologic classes Prostaglandin Analog [EPC], Prostaglandins [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218196-001 BIMATOPROST BIMATOPROST 0.01% SOLUTION/DROPS / OPHTHALMIC AB 2025-03-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218196-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A218196-001 BIMATOPROST 0.01% SOLUTION/DROPS / OPHTHALMIC AB 2025-03-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218196-001 BIMATOPROST 0.01% SOLUTION/DROPS / OPHTHALMIC AB 2025-03-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218196-001 BIMATOPROST 0.01% SOLUTION/DROPS / OPHTHALMIC AB 2025-03-17 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218196-001 BIMATOPROST 0.01% SOLUTION/DROPS / OPHTHALMIC AB 2025-03-17 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A218196-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218196-001 AB 1 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218196-001 AB 1 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218196-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Bimatoprost
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BIMATOPROST .1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination QXS94885MZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1009339 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81469-291-05 Bimatoprost 1 in 1 CARTON SOLUTION/ DROPS 1 1 81469-291-05 Bimatoprost 5 mL in 1 BOTTLE SOLUTION/ DROPS 5 1 81469-291-25 Bimatoprost 2.5 mL in 1 BOTTLE SOLUTION/ DROPS 2.5 1 81469-291-25 Bimatoprost 1 in 1 CARTON SOLUTION/ DROPS 1 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 81469-291-05 81469029105 1 BOTTLE in 1 CARTON (81469-291-05) / 5 mL in 1 BOTTLE 1 bottle 2026-05-01 No No Current 81469-291-25 81469029125 1 BOTTLE in 1 CARTON (81469-291-25) / 2.5 mL in 1 BOTTLE 1 bottle 2026-05-01 No No Current