Home NDC 42571-461 OFLOXACIN
Product NDC 42571-461
11-digit product format 425710461
Labeler code 42571
Product ID 42571-461_4f66b7f2-7abd-8300-e063-6294a90aab82
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name OFLOXACIN OPHTHALMIC
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Micro Labs Limited
Application ANDA218557
Marketing category ANDA
Marketing start 2026-10-15
Substance OFLOXACIN
Active strength 3 mg/mL
Pharmacologic classes Quinolone Antimicrobial [EPC], Quinolones [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 44 .
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 A218557-001 OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2026-04-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218557-001 AT
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 2026-10-15 13:18:30 2026-09 A218557-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2026-04-08 c2088c7a36db…2026-09-14 22:38:34 2026-08 A218557-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2026-04-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218557-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2026-04-08 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218557-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2026-04-08 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 42571-461-92 42571046192 1 BOTTLE, DROPPER in 1 CARTON (42571-461-92) / 5 mL in 1 BOTTLE, DROPPER 2026-10-15 No No Historical