Home NDC 68180-392 CIPROFLOXACIN
Product NDC 68180-392
11-digit product format 681800392
Labeler code 68180
Product ID 68180-392_50b98e4c-606c-4337-b579-9214ea21ea86
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CIPROFLOXACIN
Dosage form KIT
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA200563
Marketing category ANDA
Marketing start 2014-06-06
Marketing end 0000-00-00
Active strength 0
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68180-392-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68180-392-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68180-392-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68180-392-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68180-392-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68180-392-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68180-392-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68180-392-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68180-392-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68180-392-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68180-392-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68180-392-01 557ba5c1ecfa…9c80585c8c6e…
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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CIPROFLOXACIN ACTIVE INGREDIENT 5E8K9I0O4U CIPROFLOXACIN ( CIPROFLOXACIN ) KIT [LUPIN PHARMACEUTICALS, INC.] 3 CIPROFLOXACIN ACTIVE MOIETY 5E8K9I0O4U CIPROFLOXACIN ( CIPROFLOXACIN ) KIT [LUPIN PHARMACEUTICALS, INC.] 3 AMMONIUM GLYCYRRHIZATE INACTIVE INGREDIENT 3VRD35U26C CIPROFLOXACIN ( CIPROFLOXACIN ) KIT [LUPIN PHARMACEUTICALS, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CIPROFLOXACIN ( CIPROFLOXACIN ) KIT [LUPIN PHARMACEUTICALS, INC.] 3 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CIPROFLOXACIN ( CIPROFLOXACIN ) KIT [LUPIN PHARMACEUTICALS, INC.] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CIPROFLOXACIN ( CIPROFLOXACIN ) KIT [LUPIN PHARMACEUTICALS, INC.] 3 DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER INACTIVE INGREDIENT 905HNO1SIH CIPROFLOXACIN ( CIPROFLOXACIN ) KIT [LUPIN PHARMACEUTICALS, INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CIPROFLOXACIN ( CIPROFLOXACIN ) KIT [LUPIN PHARMACEUTICALS, INC.] 3 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U CIPROFLOXACIN ( CIPROFLOXACIN ) KIT [LUPIN PHARMACEUTICALS, INC.] 3 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH CIPROFLOXACIN ( CIPROFLOXACIN ) KIT [LUPIN PHARMACEUTICALS, INC.] 3 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 CIPROFLOXACIN ( CIPROFLOXACIN ) KIT [LUPIN PHARMACEUTICALS, INC.] 3 SUCROSE INACTIVE INGREDIENT C151H8M554 CIPROFLOXACIN ( CIPROFLOXACIN ) KIT [LUPIN PHARMACEUTICALS, INC.] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U CIPROFLOXACIN ( CIPROFLOXACIN ) KIT [LUPIN PHARMACEUTICALS, INC.] 3
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.