Home NDC 53746-831 Ciprofloxacin and Dexamethasone
Product NDC 53746-831
11-digit product format 537460831
Labeler code 53746
Product ID 53746-831_718cd533-d887-4ef1-a7d0-fca696242bb2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ciprofloxacin and Dexamethasone
Dosage form SUSPENSION/ DROPS
Route AURICULAR (OTIC)
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA216501
Marketing category ANDA
Marketing start 2024-03-26
Substance CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE
Active strength 3; 1 mg/mL; mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], 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 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 A216501-001 CIPROFLOXACIN AND DEXAMETHASONE CIPROFLOXACIN; DEXAMETHASONE 0.3%;0.1% SUSPENSION/DROPS / OTIC AB 2024-03-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216501-001 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 A216501-001 CIPROFLOXACIN AND DEXAMETHASONE 0.3%;0.1% SUSPENSION/DROPS / OTIC AB 2024-03-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216501-001 CIPROFLOXACIN AND DEXAMETHASONE 0.3%;0.1% SUSPENSION/DROPS / OTIC AB 2024-03-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216501-001 CIPROFLOXACIN AND DEXAMETHASONE 0.3%;0.1% SUSPENSION/DROPS / OTIC AB 2024-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216501-001 CIPROFLOXACIN AND DEXAMETHASONE 0.3%;0.1% SUSPENSION/DROPS / OTIC AB 2024-03-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216501-001 CIPROFLOXACIN AND DEXAMETHASONE 0.3%;0.1% SUSPENSION/DROPS / OTIC AB 2024-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216501-001 CIPROFLOXACIN; DEXAMETHASONE 0.3%;0.1% SUSPENSION/DROPS / OTIC AB 2024-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216501-001 CIPROFLOXACIN; DEXAMETHASONE 0.3%;0.1% SUSPENSION/DROPS / OTIC AB 2024-03-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216501-001 CIPROFLOXACIN; DEXAMETHASONE 0.3%;0.1% SUSPENSION/DROPS / OTIC AB 2024-03-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216501-001 CIPROFLOXACIN; DEXAMETHASONE 0.3%;0.1% SUSPENSION/DROPS / OTIC AB 2024-03-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216501-001 CIPROFLOXACIN; DEXAMETHASONE 0.3%;0.1% SUSPENSION/DROPS / OTIC AB 2024-03-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216501-001 CIPROFLOXACIN; DEXAMETHASONE 0.3%;0.1% SUSPENSION/DROPS / OTIC AB 2024-03-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216501-001 CIPROFLOXACIN; DEXAMETHASONE 0.3%;0.1% SUSPENSION/DROPS / OTIC AB 2024-03-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216501-001 CIPROFLOXACIN; DEXAMETHASONE 0.3%;0.1% SUSPENSION/DROPS / OTIC AB 2024-03-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216501-001 CIPROFLOXACIN; DEXAMETHASONE 0.3%;0.1% SUSPENSION/DROPS / OTIC AB 2024-03-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216501-001 CIPROFLOXACIN; DEXAMETHASONE 0.3%;0.1% SUSPENSION/DROPS / OTIC AB 2024-03-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216501-001 CIPROFLOXACIN; DEXAMETHASONE 0.3%;0.1% SUSPENSION/DROPS / OTIC AB 2024-03-22 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216501-001 CIPROFLOXACIN AND DEXAMETHASONE 0.3%;0.1% SUSPENSION/DROPS / OTIC AB 2024-03-22 a50c72e98297…
Observed Orange Book normalized TE history# 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 and Dexamethasone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL DEXAMETHASONE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4BA73M5E37 Internal UNII lookup 7S5I7G3JQL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 403908 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 53746-831-53 Ciprofloxacin and Dexamethasone 7.5 mL in 1 BOTTLE, PLASTIC SUSPENSION/ DROPS 7.5 7 53746-831-53 Ciprofloxacin and Dexamethasone 1 in 1 CARTON SUSPENSION/ DROPS 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53746-831 CIPROFLOXACIN AND DEXAMETHASONE SUSPENSION/ DROPS [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 7 Current NDC, 2 package rows 20240328_55426495-5fd1-44ca-afcc-ffbbb0a0a569.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 Marketing start Sample Exclude flag Status 53746-831-53 53746083153 1 BOTTLE, PLASTIC in 1 CARTON (53746-831-53) / 7.5 mL in 1 BOTTLE, PLASTIC 2024-03-26 No No Current