Home NDC 64950-381 Ciprofloxacin Otic
Product NDC 64950-381
11-digit product format 649500381
Labeler code 64950
Product ID 64950-381_fc69400c-8758-444f-937d-ba2ac4fc95d9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ciprofloxacin
Dosage form SOLUTION/ DROPS
Route AURICULAR (OTIC)
Labeler Genus Lifesciences
Application ANDA217887
Marketing category ANDA
Marketing start 2024-12-01
Marketing end 2028-11-30
Substance CIPROFLOXACIN
Active strength .5 mg/.25mL
Pharmacologic classes Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A217887-001 CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS / OTIC AB 2024-11-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217887-001 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 2026-09-14 22:38:34 2026-08 A217887-001 CIPROFLOXACIN HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS / OTIC AB 2024-11-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217887-001 CIPROFLOXACIN HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS / OTIC AB 2024-11-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217887-001 CIPROFLOXACIN HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS / OTIC AB 2024-11-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217887-001 CIPROFLOXACIN HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS / OTIC AB 2024-11-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217887-001 CIPROFLOXACIN HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS / OTIC AB 2024-11-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217887-001 CIPROFLOXACIN HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS / OTIC AB 2024-11-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217887-001 CIPROFLOXACIN HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS / OTIC AB 2024-11-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217887-001 CIPROFLOXACIN HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS / OTIC AB 2024-11-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217887-001 CIPROFLOXACIN HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS / OTIC AB 2024-11-05 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217887-001 CIPROFLOXACIN HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS / OTIC AB 2024-11-05 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217887-001 CIPROFLOXACIN HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS / OTIC AB 2024-11-05 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217887-001 CGT 2025-06-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217887-001 CGT 2025-06-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217887-001 CGT 2025-06-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217887-001 CGT 2025-06-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217887-001 CGT 2025-06-11 03ed91905a0d…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Ciprofloxacin Otic Active Ingredients# Ingredient, Strength table Ingredient Strength CIPROFLOXACIN .5 mg/.25mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64950-381-14 Ciprofloxacin Otic 0.25 mL in 1 VIAL SOLUTION/ DROPS 0.25 1 64950-381-14 Ciprofloxacin Otic 14 in 1 CARTON SOLUTION/ DROPS 14 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64950-381 CIPROFLOXACIN OTIC (CIPROFLOXACIN) SOLUTION/ DROPS [GENUS LIFESCIENCES] 1 Current NDC, 2 package rows 20250417_51dde3f2-adb1-4ed8-83c6-1f63723a2529.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64950-381-14 64950038114 14 VIAL in 1 CARTON (64950-381-14) / .25 mL in 1 VIAL 14 vial 2024-12-01 2028-11-30 No No Historical