Home NDC 62135-392 ciprofloxacin
Product NDC 62135-392
11-digit product format 621350392
Labeler code 62135
Product ID 62135-392_459c475d-c9e2-ffa6-e063-6394a90add66
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ciprofloxacin
Dosage form KIT
Labeler Chartwell RX, LLC
Application ANDA200563
Marketing category ANDA
Marketing start 2014-03-05
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A200563-001 CIPROFLOXACIN CIPROFLOXACIN 250MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 A200563-002 CIPROFLOXACIN CIPROFLOXACIN 500MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05
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 · 84 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 2026-08-18 06:07:40 2026-07 A200563-001 CIPROFLOXACIN 250MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200563-002 CIPROFLOXACIN 500MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200563-001 CIPROFLOXACIN 250MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200563-002 CIPROFLOXACIN 500MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200563-001 CIPROFLOXACIN 250MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200563-002 CIPROFLOXACIN 500MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200563-001 CIPROFLOXACIN 250MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200563-002 CIPROFLOXACIN 500MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200563-001 CIPROFLOXACIN 250MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200563-002 CIPROFLOXACIN 500MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200563-001 CIPROFLOXACIN 250MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200563-002 CIPROFLOXACIN 500MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200563-001 CIPROFLOXACIN 250MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200563-002 CIPROFLOXACIN 500MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200563-001 CIPROFLOXACIN 250MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200563-002 CIPROFLOXACIN 500MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200563-001 CIPROFLOXACIN 250MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200563-002 CIPROFLOXACIN 500MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200563-001 CIPROFLOXACIN 250MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200563-002 CIPROFLOXACIN 500MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200563-001 CIPROFLOXACIN 250MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200563-002 CIPROFLOXACIN 500MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200563-001 CIPROFLOXACIN 250MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200563-002 CIPROFLOXACIN 500MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200563-001 CIPROFLOXACIN 250MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200563-002 CIPROFLOXACIN 500MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200563-001 CIPROFLOXACIN 250MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200563-002 CIPROFLOXACIN 500MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200563-001 CIPROFLOXACIN 250MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A200563-002 CIPROFLOXACIN 500MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200563-001 CIPROFLOXACIN 250MG/5ML FOR SUSPENSION / ORAL 2014-03-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200563-002 CIPROFLOXACIN 500MG/5ML FOR SUSPENSION / ORAL 2014-03-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200563-001 CIPROFLOXACIN 250MG/5ML FOR SUSPENSION / ORAL 2014-03-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A200563-002 CIPROFLOXACIN 500MG/5ML FOR SUSPENSION / ORAL 2014-03-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200563-001 CIPROFLOXACIN 250MG/5ML FOR SUSPENSION / ORAL 2014-03-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A200563-002 CIPROFLOXACIN 500MG/5ML FOR SUSPENSION / ORAL 2014-03-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200563-001 CIPROFLOXACIN 250MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A200563-002 CIPROFLOXACIN 500MG/5ML FOR SUSPENSION / ORAL AB 2014-03-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200563-001 CIPROFLOXACIN 250MG/5ML FOR SUSPENSION / ORAL 2014-03-05 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A200563-002 CIPROFLOXACIN 500MG/5ML FOR SUSPENSION / ORAL 2014-03-05 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 54 observed states.
Additional Listing Data#
Finished product Yes
Brand name base ciprofloxacin
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309308 Internal RxNorm lookup 309310 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 62135-392-42 ciprofloxacin 1 in 1 KIT KIT 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-392 CIPROFLOXACIN KIT [CHARTWELL RX, LLC] 3 Current NDC, 1 package rows 20230322_905503ef-4277-44ca-aa4a-5a969a041e16.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 62135-392-42 62135039242 1 KIT in 1 KIT (62135-392-42) * 100 mL in 1 BOTTLE * 100 mL in 1 BOTTLE 1 kit 2023-01-27 No No Current