Home NDC 64950-381 Ciprofloxacin Otic
Product NDC 64950-381
11-digit product format 649500381
Labeler code 64950
Product ID 64950-381_3f726b10-ef7b-47d6-96c9-e1a7ee5461d9
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
Substance CIPROFLOXACIN
Active strength .5 mg/.25mL
Pharmacologic classes Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 2026-08-18 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…
Additional Listing Data#
Finished product Yes
Brand name base Ciprofloxacin Otic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CIPROFLOXACIN .5 mg/.25mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5E8K9I0O4U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 848956 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 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
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 · 1 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 64950-381-14 64950038114 14 VIAL in 1 CARTON (64950-381-14) / .25 mL in 1 VIAL 14 vial 2024-12-01 No No Current