Home NDC 0713-0851 ciprofloxacin hydrochloride and hydrocortisone
Product NDC 0713-0851
11-digit product format 007130851
Labeler code 0713
Product ID 0713-0851_44ea2018-99d5-8f97-e063-6294a90ab0f2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ciprofloxacin hydrochloride and hydrocortisone
Dosage form SUSPENSION/ DROPS
Route AURICULAR (OTIC)
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA218273
Marketing category ANDA
Marketing start 2025-12-04
Substance CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE
Active strength 2; 10 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 A218273-001 CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE EQ 0.2% BASE;1% SUSPENSION/DROPS / OTIC AB 2025-11-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218273-001 AB
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A218273-001 CGT 2026-06-02
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 A218273-001 CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE EQ 0.2% BASE;1% SUSPENSION/DROPS / OTIC AB 2025-11-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218273-001 CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE EQ 0.2% BASE;1% SUSPENSION/DROPS / OTIC AB 2025-11-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218273-001 CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE EQ 0.2% BASE;1% SUSPENSION/DROPS / OTIC AB 2025-11-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218273-001 CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE EQ 0.2% BASE;1% SUSPENSION/DROPS / OTIC AB 2025-11-10 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218273-001 CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE EQ 0.2% BASE;1% SUSPENSION/DROPS / OTIC AB 2025-11-10 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 2026-09-14 22:38:34 2026-08 A218273-001 CGT 2026-06-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218273-001 CGT 2026-06-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218273-001 CGT 2026-06-02 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218273-001 CGT 2026-06-02 a50c72e98297…
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 hydrochloride and hydrocortisone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CIPROFLOXACIN HYDROCHLORIDE 2 mg/mL HYDROCORTISONE 10 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 WI4X0X7BPJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309305 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 0713-0851-09 ciprofloxacin hydrochloride and hydrocortisone 10 mL in 1 BOTTLE SUSPENSION/ DROPS 10 1 0713-0851-09 ciprofloxacin hydrochloride and hydrocortisone 1 in 1 CARTON SUSPENSION/ DROPS 1 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 · 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 0713-0851-09 00713085109 1 BOTTLE in 1 CARTON (0713-0851-09) / 10 mL in 1 BOTTLE 1 bottle 2025-12-04 No No Current