Home NDC 60760-676 Ciprofloxacin
Product NDC 60760-676
11-digit product format 607600676
Labeler code 60760
Product ID 60760-676_54bb572a-db6c-c5fa-e063-6394a90a1b64
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ciprofloxacin
Dosage form TABLET, COATED
Route ORAL
Labeler St. Mary's Medical Park Pharmacy
Application ANDA208921
Marketing category ANDA
Marketing start 2021-05-21
Substance CIPROFLOXACIN HYDROCHLORIDE
Active strength 500 mg/1
Pharmacologic classes Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [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 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208921-001 CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 A208921-002 CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
Product history page 1 of 3 · 86 observed 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 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CIPROFLOXACIN HYDROCHLORIDE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4BA73M5E37 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309309 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 60760-676-10 Ciprofloxacin 10 in 1 BOTTLE, PLASTIC TABLET, COATED 10 1 60760-676-20 Ciprofloxacin 20 in 1 BOTTLE, PLASTIC TABLET, COATED 20 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60760-676 CIPROFLOXACIN TABLET, COATED [ST. MARY'S MEDICAL PARK PHARMACY] 1 Current NDC, Legacy NDC, 2 package rows 20210529_c32ccb5f-b9d7-0aff-e053-2995a90afe6d.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 3 of 3 · 43 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 60760-676-10 60760067610 10 TABLET, COATED in 1 BOTTLE, PLASTIC (60760-676-10) 2021-05-28 0000-00-00 No No Current 60760-676-20 60760067620 20 TABLET, COATED in 1 BOTTLE, PLASTIC (60760-676-20) 2021-05-21 0000-00-00 No No Current