Home NDC 44001-321 FACTIVE
Product NDC 44001-321
11-digit product format 440010321
Labeler code 44001
Product ID 44001-321_f5157025-9ab5-4697-81bc-1adb13ea1dfc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gemifloxacin mesylate
Dosage form TABLET
Route ORAL
Labeler Merus Labs International Inc.
Application NDA021158
Marketing category NDA
Marketing start 2003-04-04
Marketing end 0000-00-00
Substance GEMIFLOXACIN MESYLATE
Active strength 320 mg/1
Pharmacologic classes Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag E
Listing certified through 2017-12-31
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 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N021158-001 FACTIVE GEMIFLOXACIN MESYLATE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-04-04
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 2 · 44 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 2026-10-15 13:18:30 2026-09 N021158-001 FACTIVE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-04-04 c2088c7a36db…2026-09-14 22:38:34 2026-08 N021158-001 FACTIVE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-04-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021158-001 FACTIVE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-04-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021158-001 FACTIVE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-04-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021158-001 FACTIVE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-04-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021158-001 FACTIVE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-04-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021158-001 FACTIVE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-04-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021158-001 FACTIVE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-04-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021158-001 FACTIVE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-04-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021158-001 FACTIVE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-04-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021158-001 FACTIVE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-04-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021158-001 FACTIVE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-04-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021158-001 FACTIVE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-04-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021158-001 FACTIVE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-04-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021158-001 FACTIVE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-04-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021158-001 FACTIVE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-04-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021158-001 FACTIVE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-04-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021158-001 FACTIVE EQ 320MG BASE TABLET / ORAL RLD 2003-04-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021158-001 FACTIVE EQ 320MG BASE TABLET / ORAL RLD 2003-04-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021158-001 FACTIVE EQ 320MG BASE TABLET / ORAL RLD 2003-04-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021158-001 FACTIVE EQ 320MG BASE TABLET / ORAL AB RLD, RS 2003-04-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021158-001 FACTIVE EQ 320MG BASE TABLET / ORAL RLD 2003-04-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021158-001 FACTIVE EQ 320MG BASE TABLET / ORAL AB RLD, RS 2003-04-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021158-001 FACTIVE EQ 320MG BASE TABLET / ORAL AB RLD, RS 2003-04-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021158-001 FACTIVE EQ 320MG BASE TABLET / ORAL AB RLD, RS 2003-04-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021158-001 FACTIVE EQ 320MG BASE TABLET / ORAL AB RLD, RS 2003-04-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021158-001 FACTIVE EQ 320MG BASE TABLET / ORAL AB RLD, RS 2003-04-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021158-001 FACTIVE EQ 320MG BASE TABLET / ORAL AB RLD, RS 2003-04-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021158-001 FACTIVE EQ 320MG BASE TABLET / ORAL AB RLD, RS 2003-04-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021158-001 FACTIVE EQ 320MG BASE TABLET / ORAL AB RLD, RS 2003-04-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021158-001 FACTIVE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-04-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021158-001 FACTIVE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-04-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021158-001 FACTIVE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-04-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021158-001 FACTIVE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-04-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021158-001 FACTIVE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-04-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021158-001 FACTIVE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-04-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021158-001 FACTIVE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-04-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021158-001 FACTIVE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-04-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021158-001 FACTIVE EQ 320MG BASE TABLET / ORAL RLD 2003-04-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021158-001 FACTIVE EQ 320MG BASE TABLET / ORAL RLD 2003-04-04 3a93d1ddd44b…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021158-001 6340689 2019-09-14 U-512 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021158-001 6262071 2019-09-21 U-513 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021158-001 6331550 2019-09-21 U-511 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021158-001 6455540 2019-09-21 U-511 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021158-001 6803376 2019-09-21 U-609 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021158-001 6803376 2019-09-21 U-608 Drug substance, Drug product 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N021158-001 6340689 2019-09-14 U-512 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021158-001 6262071 2019-09-21 U-513 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021158-001 6331550 2019-09-21 U-511 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021158-001 6455540 2019-09-21 U-511 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021158-001 6803376 2019-09-21 U-609 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021158-001 6803376 2019-09-21 U-608 Drug substance, Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021158-001 6340689 2019-09-14 U-512 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021158-001 6262071 2019-09-21 U-513 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021158-001 6331550 2019-09-21 U-511 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021158-001 6455540 2019-09-21 U-511 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021158-001 6803376 2019-09-21 U-609 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021158-001 6803376 2019-09-21 U-608 Drug substance, Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021158-001 6340689 2019-09-14 U-512 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021158-001 6262071 2019-09-21 U-513 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021158-001 6331550 2019-09-21 U-511 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021158-001 6455540 2019-09-21 U-511 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021158-001 6803376 2019-09-21 U-609 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021158-001 6803376 2019-09-21 U-608 Drug substance, Drug product ea99ee380514…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 44001-321-05 FACTIVE 5 in 1 BLISTER PACK TABLET 5 3 44001-321-07 FACTIVE 7 in 1 BLISTER PACK TABLET 7 3
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44001-321 FACTIVE (GEMIFLOXACIN MESYLATE) TABLET [MERUS LABS INTERNATIONAL INC.] 3 Legacy NDC, 2 package rows 20160810_63f60426-e27f-4258-9bfc-b4a15ebdca83.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 44001-321-05 44001032105 5 in 1 BLISTER PACK Historical 44001-321-07 44001032107 7 in 1 BLISTER PACK Historical