Home NDC 67296-2222-3 Moxifloxacin ophthalmic solution
Product NDC 67296-2222
Requested package NDC 67296-2222-3
11-digit product format 672962222
Labeler code 67296
Product ID 67296-2222_4fb56eba-b3d2-acca-e063-6394a90aba1f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Moxifloxacin
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Redpharm Drug
Application ANDA217988
Marketing category ANDA
Marketing start 2025-01-27
Substance MOXIFLOXACIN HYDROCHLORIDE
Active strength 5 mg/mL
Pharmacologic classes Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [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 A217988-001 MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2025-01-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217988-001 AT1
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 A217988-001 MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2025-01-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217988-001 MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2025-01-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217988-001 MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2025-01-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217988-001 MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2025-01-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217988-001 MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2025-01-27 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217988-001 MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2025-01-27 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Moxifloxacin ophthalmic solution
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MOXIFLOXACIN HYDROCHLORIDE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C53598599T Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 403818 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 67296-2222-3 Moxifloxacin ophthalmic solution 1 in 1 CARTON SOLUTION/ DROPS 1 1 67296-2222-3 Moxifloxacin ophthalmic solution 3 mL in 1 BOTTLE SOLUTION/ DROPS 3 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 67296-2222-3 67296222203 1 BOTTLE in 1 CARTON (67296-2222-3) / 3 mL in 1 BOTTLE 1 bottle 2025-01-27 No No Current