Ciprofloxacin

Product NDC: 55111-423
11-digit product format: 551110423
Labeler code: 55111
Product ID: 55111-423_52f816f4-05ac-1372-790b-a02129c1d94e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ciprofloxacin hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Dr. Reddy's Laboratories Limited
Application: ANDA077701
Marketing category: ANDA
Marketing start: 2007-10-31
Marketing end: 0000-00-00
Substance: CIPROFLOXACIN HYDROCHLORIDE; CIPROFLOXACIN
Active strength: 575 mg/1; mg/1
Pharmacologic classes: Quinolone Antimicrobial [EPC],Quinolones [CS],Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55111-423		I	Inactivated by FDA	2026-10-15
excluded package	package	55111-423	55111-423-01	I	Inactivated by FDA	2026-10-15
excluded package	package	55111-423	55111-423-05	I	Inactivated by FDA	2026-10-15
excluded package	package	55111-423	55111-423-30	I	Inactivated by FDA	2026-10-15
excluded package	package	55111-423	55111-423-78	I	Inactivated by FDA	2026-10-15

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 · 110 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	55111-423-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55111-423-78	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55111-423-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55111-423-01	`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	55111-423-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55111-423-78	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55111-423-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55111-423-01	`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	55111-423-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55111-423-78	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55111-423-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55111-423-01	`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	55111-423-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55111-423-78	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55111-423-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55111-423-01	`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	55111-423-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55111-423-78	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55111-423-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55111-423-01	`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	55111-423-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55111-423-78	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55111-423-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55111-423-01	`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	55111-423-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55111-423-78	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55111-423-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55111-423-01	`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	55111-423-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55111-423-78	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55111-423-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55111-423-01	`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	55111-423-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55111-423-78	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55111-423-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55111-423-01	`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	55111-423-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55111-423-78	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55111-423-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55111-423-01	`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	55111-423-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55111-423-78	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55111-423-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55111-423-01	`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	55111-423-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55111-423-78	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55111-423-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55111-423-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A077701-001	CIPROFLOXACIN EXTENDED RELEASE	CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE	425.2MG;EQ 574.9MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2007-03-26
A077701-002	CIPROFLOXACIN EXTENDED RELEASE	CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE	212.6MG;EQ 287.5MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-10-31

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 · 88 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	A077701-001	CIPROFLOXACIN EXTENDED RELEASE	425.2MG;EQ 574.9MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2007-03-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077701-002	CIPROFLOXACIN EXTENDED RELEASE	212.6MG;EQ 287.5MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-10-31	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077701-001	CIPROFLOXACIN EXTENDED RELEASE	425.2MG;EQ 574.9MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2007-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077701-002	CIPROFLOXACIN EXTENDED RELEASE	212.6MG;EQ 287.5MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-10-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077701-001	CIPROFLOXACIN EXTENDED RELEASE	425.2MG;EQ 574.9MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2007-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077701-002	CIPROFLOXACIN EXTENDED RELEASE	212.6MG;EQ 287.5MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077701-001	CIPROFLOXACIN EXTENDED RELEASE	425.2MG;EQ 574.9MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2007-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077701-002	CIPROFLOXACIN EXTENDED RELEASE	212.6MG;EQ 287.5MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077701-001	CIPROFLOXACIN EXTENDED RELEASE	425.2MG;EQ 574.9MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2007-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077701-002	CIPROFLOXACIN EXTENDED RELEASE	212.6MG;EQ 287.5MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077701-001	CIPROFLOXACIN EXTENDED RELEASE	425.2MG;EQ 574.9MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2007-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077701-002	CIPROFLOXACIN EXTENDED RELEASE	212.6MG;EQ 287.5MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077701-001	CIPROFLOXACIN EXTENDED RELEASE	425.2MG;EQ 574.9MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2007-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077701-002	CIPROFLOXACIN EXTENDED RELEASE	212.6MG;EQ 287.5MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077701-001	CIPROFLOXACIN EXTENDED RELEASE	425.2MG;EQ 574.9MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2007-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077701-002	CIPROFLOXACIN EXTENDED RELEASE	212.6MG;EQ 287.5MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077701-001	CIPROFLOXACIN EXTENDED RELEASE	425.2MG;EQ 574.9MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2007-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077701-002	CIPROFLOXACIN EXTENDED RELEASE	212.6MG;EQ 287.5MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077701-001	CIPROFLOXACIN EXTENDED RELEASE	425.2MG;EQ 574.9MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2007-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077701-002	CIPROFLOXACIN EXTENDED RELEASE	212.6MG;EQ 287.5MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077701-001	CIPROFLOXACIN EXTENDED RELEASE	425.2MG;EQ 574.9MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2007-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077701-002	CIPROFLOXACIN EXTENDED RELEASE	212.6MG;EQ 287.5MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077701-001	CIPROFLOXACIN EXTENDED RELEASE	425.2MG;EQ 574.9MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2007-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077701-002	CIPROFLOXACIN EXTENDED RELEASE	212.6MG;EQ 287.5MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077701-001	CIPROFLOXACIN EXTENDED RELEASE	425.2MG;EQ 574.9MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2007-03-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077701-002	CIPROFLOXACIN EXTENDED RELEASE	212.6MG;EQ 287.5MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077701-001	CIPROFLOXACIN EXTENDED RELEASE	425.2MG;EQ 574.9MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2007-03-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077701-002	CIPROFLOXACIN EXTENDED RELEASE	212.6MG;EQ 287.5MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077701-001	CIPROFLOXACIN EXTENDED RELEASE	425.2MG;EQ 574.9MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2007-03-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077701-002	CIPROFLOXACIN EXTENDED RELEASE	212.6MG;EQ 287.5MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077701-001	CIPROFLOXACIN EXTENDED RELEASE	425.2MG;EQ 574.9MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2007-03-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077701-002	CIPROFLOXACIN EXTENDED RELEASE	212.6MG;EQ 287.5MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077701-001	CIPROFLOXACIN EXTENDED RELEASE	425.2MG;EQ 574.9MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2007-03-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077701-002	CIPROFLOXACIN EXTENDED RELEASE	212.6MG;EQ 287.5MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077701-001	CIPROFLOXACIN EXTENDED RELEASE	425.2MG;EQ 574.9MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2007-03-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077701-002	CIPROFLOXACIN EXTENDED RELEASE	212.6MG;EQ 287.5MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077701-001	CIPROFLOXACIN EXTENDED RELEASE	425.2MG;EQ 574.9MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2007-03-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077701-002	CIPROFLOXACIN EXTENDED RELEASE	212.6MG;EQ 287.5MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077701-001	CIPROFLOXACIN EXTENDED RELEASE	425.2MG;EQ 574.9MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2007-03-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077701-002	CIPROFLOXACIN EXTENDED RELEASE	212.6MG;EQ 287.5MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-10-31	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077701-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077701-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077701-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077701-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077701-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077701-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077701-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077701-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077701-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077701-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077701-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077701-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077701-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077701-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077701-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077701-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077701-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077701-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077701-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077701-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077701-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077701-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077701-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077701-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077701-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077701-001	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ea50b939-d92a-4100-84f5-1c1089663837	Product name	2	20240705
90aab9f8-63f3-478d-8db8-951525a18ab1	Product name	1	20180814
200e1d3d-46da-4371-beed-747da3cb3ff8	Product name	1	20180702
9e453f34-aacb-44d5-a119-c0e3dc1fca2a	Product name	1	20160622
01eecbfe-0b50-413b-8898-6905c89b6568	Product name	1	20151228
a3304bb6-ef4e-06df-d604-35f7e883ed6c	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
de5ea793-ffd9-0308-b0ca-00d9967be4ee	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
55111-423-01	Ciprofloxacin Extended-Release Tablets
55111-423-05	Ciprofloxacin Extended-Release Tablets
55111-423-30	Ciprofloxacin Extended-Release Tablets
55111-423-78	Ciprofloxacin Extended-Release Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55111-423-01	Ciprofloxacin	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100	5
55111-423-05	Ciprofloxacin	500 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	500	5
55111-423-30	Ciprofloxacin	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30	5
55111-423-78	Ciprofloxacin	100 in 1 BOX, UNIT-DOSE	TABLET, FILM COATED, EXTENDED RE	100	5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ciprofloxacin	ACTIVE INGREDIENT	5E8K9I0O4U	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	5
ciprofloxacin hydrochloride	ACTIVE INGREDIENT	4BA73M5E37	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	5
ciprofloxacin	ACTIVE MOIETY	5E8K9I0O4U	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	5
crospovidone	INACTIVE INGREDIENT	68401960MK	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	5
ethylcelluloses	INACTIVE INGREDIENT	7Z8S9VYZ4B	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	5
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	5
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	5
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	5
succinic acid	INACTIVE INGREDIENT	AB6MNQ6J6L	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	5
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55111-423	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	5	Legacy NDC, 4 package rows	20120228_4ab110e4-7b91-42aa-8052-f24cd79293f0.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4BA73M5E37	CIPROFLOXACIN HYDROCHLORIDE	86393-32-0	CIPROFLOXACIN HYDROCHLORIDE
5E8K9I0O4U	CIPROFLOXACIN	85721-33-1	CIPROFLOXACIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
403921	ciprofloxacin 1000 MG 24HR Extended Release Oral Tablet	PSN	4ab110e4-7b91-42aa-8052-f24cd79293f0	5
359383	ciprofloxacin 500 MG 24HR Extended Release Oral Tablet	PSN	4ab110e4-7b91-42aa-8052-f24cd79293f0	5
403921	24 HR ciprofloxacin 1000 MG Extended Release Oral Tablet	SCD	4ab110e4-7b91-42aa-8052-f24cd79293f0	5
359383	24 HR ciprofloxacin 500 MG Extended Release Oral Tablet	SCD	4ab110e4-7b91-42aa-8052-f24cd79293f0	5
403921	ciprofloxacin 1000 MG 24 HR Extended Release Oral Tablet	SY	4ab110e4-7b91-42aa-8052-f24cd79293f0	5
359383	ciprofloxacin 500 MG 24 HR Extended Release Oral Tablet	SY	4ab110e4-7b91-42aa-8052-f24cd79293f0	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
55111-423-01	55111042301	100 in 1 BOTTLE	Historical
55111-423-05	55111042305	500 in 1 BOTTLE	Historical
55111-423-30	55111042330	30 in 1 BOTTLE	Historical
55111-423-78	55111042378	100 in 1 BOX, UNIT-DOSE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ciprofloxacin Extended-Release Tablets	Dr. Reddy's Laboratories Limited \| Dr.Reddy's Laboratories Limited	2011-08-30	HUMAN PRESCRIPTION DRUG LABEL	5