Ciprofloxacin

Product NDC: 58657-676
11-digit product format: 586570676
Labeler code: 58657
Product ID: 58657-676_41b40647-01ce-1916-e063-6394a90aaadd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ciprofloxacin
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Method Pharmaceuticals, LLC
Application: ANDA208921
Marketing category: ANDA
Marketing start: 2020-08-12
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: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	58657-676	58657-676-50	D	Discontinued by firm		2026-08-17

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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
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.

Application-product, TE code table
Application-product	TE code
A208921-001	AB
A208921-002	AB

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	Approval date	Source SHA-256
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…`
2022-03-09 01:35 UTC	2022-03	A208921-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2018-06-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208921-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2018-06-22	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A208921-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208921-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208921-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208921-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208921-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208921-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208921-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208921-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208921-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208921-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208921-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208921-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208921-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208921-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208921-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208921-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208921-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208921-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208921-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208921-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208921-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208921-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208921-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208921-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208921-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208921-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208921-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208921-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208921-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208921-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208921-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208921-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208921-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208921-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208921-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208921-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208921-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208921-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208921-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208921-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ciprofloxacin
Listing expiration: 2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197511	Internal RxNorm lookup
309309	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
acb03e72-ce94-58c5-e053-2a95a90a683a	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58657-676-01	Ciprofloxacin	100 in 1 BOTTLE	TABLET, COATED	100		8
58657-676-50	Ciprofloxacin	500 in 1 BOTTLE	TABLET, COATED	500		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58657-676	CIPROFLOXACIN TABLET, COATED [METHOD PHARMACEUTICALS, LLC]	7	Current NDC, Legacy NDC, 2 package rows	20241201_acb03e72-ce94-58c5-e053-2a95a90a683a.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 3 · 44 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ciprofloxacin	CIPROFOLXACIN	REMEDYREPACK INC.	c527d138-e32c-418f-9573-a3d8a796279f	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFLOXACIN	St. Mary's Medical Park Pharmacy	348e810c-e572-f3d2-e063-6394a90a0855	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFOLXACIN	Asclemed USA, Inc.	c4eecdf8-9e50-4e44-aca1-b9c19317d52a	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFLOXACIN	St. Mary's Medical Park Pharmacy	c32ccb5f-b9d7-0aff-e053-2995a90afe6d	2026-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFOLXACIN	ST. MARY'S MEDICAL PARK PHARMACY	24c43000-7620-3869-e063-6394a90a9631	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFLOXACIN	Bryant Ranch Prepack	5af16acc-51ce-41ed-b1c4-6b3fb38ef515	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFLOXACIN	Bryant Ranch Prepack	a05035e1-f941-4f7c-9321-91dd50ab149b	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFOLXACIN	Sportpharm LLC	d38b5160-4c1c-41d9-8f13-f9f877778f9c	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFOLXACIN	REMEDYREPACK INC.	4edc4fda-7834-46cc-a0ed-22f117e6e10b	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFOLXACIN	Proficient Rx LP	9f00ae9d-8707-4275-9eba-2ed72db8aea1	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFOLXACIN	Preferred Pharmaceuticals Inc.	4425d454-210d-4b9f-88ad-6b32a9e0d3bd	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFLOXACIN	Preferred Pharmaceuticals Inc.	18414c5a-8153-44f7-b27a-90c290af0a23	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals,Inc.	c2d8dcc9-23b0-75bb-e053-2995a90a02c8	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFLOXACIN	Direct_Rx	351b41db-622f-a1eb-e063-6294a90a5667	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals,Inc.	bf52e242-199b-4206-e053-2a95a90a1eb7	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals,Inc.	bf8d4359-a850-97b7-e053-2a95a90aa66a	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFLOXACIN	Northwind Health Company, LLC	f6debb60-d885-230b-e053-6394a90ad73a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFLOXACIN TABLETS	Yiling Pharmaceutical, Inc.	6fd3da0b-7428-ac8f-e053-2a91aa0aed9f	2025-12-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFOLXACIN	Redpharm Drug	3253a41f-4f0a-5d83-e063-6294a90a890c	2025-12-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFOLXACIN	NuCare Pharmaceutical, Inc.	24760182-4be8-9f43-e063-6294a90a269e	2025-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921

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
309309	ciprofloxacin 500 MG Oral Tablet	PSN	a05035e1-f941-4f7c-9321-91dd50ab149b	104
309309	ciprofloxacin 500 MG Oral Tablet	SCD	a05035e1-f941-4f7c-9321-91dd50ab149b	104
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	a05035e1-f941-4f7c-9321-91dd50ab149b	104
197511	ciprofloxacin 250 MG Oral Tablet	PSN	acb03e72-ce94-58c5-e053-2a95a90a683a	8
309309	ciprofloxacin 500 MG Oral Tablet	PSN	acb03e72-ce94-58c5-e053-2a95a90a683a	8
197511	ciprofloxacin 250 MG Oral Tablet	SCD	acb03e72-ce94-58c5-e053-2a95a90a683a	8
309309	ciprofloxacin 500 MG Oral Tablet	SCD	acb03e72-ce94-58c5-e053-2a95a90a683a	8
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	acb03e72-ce94-58c5-e053-2a95a90a683a	8
197511	ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral Tablet	SY	acb03e72-ce94-58c5-e053-2a95a90a683a	8
309309	ciprofloxacin 500 MG Oral Tablet	PSN	bf8d4359-a850-97b7-e053-2a95a90aa66a	2
309309	ciprofloxacin 500 MG Oral Tablet	PSN	17435f05-f04d-e792-e063-6294a90af145	2
309309	ciprofloxacin 500 MG Oral Tablet	PSN	82d568d3-9637-4a21-a56e-cc9dc210dee4	2
309309	ciprofloxacin 500 MG Oral Tablet	PSN	c2d8dcc9-23b0-75bb-e053-2995a90a02c8	2
309309	ciprofloxacin 500 MG Oral Tablet	PSN	f6debb60-d885-230b-e053-6394a90ad73a	2
309309	ciprofloxacin 500 MG Oral Tablet	SCD	c2d8dcc9-23b0-75bb-e053-2995a90a02c8	2
309309	ciprofloxacin 500 MG Oral Tablet	SCD	f6debb60-d885-230b-e053-6394a90ad73a	2
309309	ciprofloxacin 500 MG Oral Tablet	SCD	bf8d4359-a850-97b7-e053-2a95a90aa66a	2
309309	ciprofloxacin 500 MG Oral Tablet	SCD	82d568d3-9637-4a21-a56e-cc9dc210dee4	2
309309	ciprofloxacin 500 MG Oral Tablet	SCD	17435f05-f04d-e792-e063-6294a90af145	2
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	bf8d4359-a850-97b7-e053-2a95a90aa66a	2
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	c2d8dcc9-23b0-75bb-e053-2995a90a02c8	2
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	82d568d3-9637-4a21-a56e-cc9dc210dee4	2
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	17435f05-f04d-e792-e063-6294a90af145	2
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	f6debb60-d885-230b-e053-6394a90ad73a	2
309309	ciprofloxacin 500 MG Oral Tablet	PSN	c32ccb5f-b9d7-0aff-e053-2995a90afe6d	1
309309	ciprofloxacin 500 MG Oral Tablet	PSN	f3c3181e-4e52-3070-e053-2a95a90aa92f	1
309309	ciprofloxacin 500 MG Oral Tablet	SCD	c32ccb5f-b9d7-0aff-e053-2995a90afe6d	1
309309	ciprofloxacin 500 MG Oral Tablet	SCD	f3c3181e-4e52-3070-e053-2a95a90aa92f	1
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	c32ccb5f-b9d7-0aff-e053-2995a90afe6d	1
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	f3c3181e-4e52-3070-e053-2a95a90aa92f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
58657-676-01	58657067601	100 TABLET, COATED in 1 BOTTLE (58657-676-01)	2020-08-12	0000-00-00	No	No	Current
58657-676-50	58657067650	500 TABLET, COATED in 1 BOTTLE (58657-676-50)	2020-08-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ciprofloxacin	St. Mary's Medical Park Pharmacy	2026-06-20	HUMAN PRESCRIPTION DRUG LABEL	2
Ciprofloxacin	Bryant Ranch Prepack	2026-05-28	HUMAN PRESCRIPTION DRUG LABEL	104
Ciprofloxacin	NuCare Pharmaceuticals,Inc.	2026-03-23	HUMAN PRESCRIPTION DRUG LABEL	2
Ciprofloxacin	NuCare Pharmaceuticals,Inc.	2026-03-03	HUMAN PRESCRIPTION DRUG LABEL	2
Ciprofloxacin	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	2
Ciprofloxacin	Method Pharmaceuticals, LLC	2025-10-21	HUMAN PRESCRIPTION DRUG LABEL	8
Ciprofloxacin	REMEDYREPACK INC.	2025-09-08	HUMAN PRESCRIPTION DRUG LABEL	8
Ciprofloxacin	Redpharm Drug	2025-01-23	HUMAN PRESCRIPTION DRUG LABEL	2
Ciprofloxacin	RPK Pharmaceuticals, Inc.	2023-08-07	HUMAN PRESCRIPTION DRUG LABEL	2
Ciprofloxacin	A-S Medication Solutions	2023-02-06	HUMAN PRESCRIPTION DRUG LABEL	3
CIPROFLOXACIN TABLETS, for oral use Initial U.S. Approval: 1987	Pharmasource Meds, LLC	2023-02-02	HUMAN PRESCRIPTION DRUG LABEL	1
Ciprofloxacin	RedPharm Drug, Inc.	2023-02-02	HUMAN PRESCRIPTION DRUG LABEL	1
Ciprofloxacin	Bryant Ranch Prepack	2022-02-09	HUMAN PRESCRIPTION DRUG LABEL	101
Ciprofloxacin	Bryant Ranch Prepack	2021-02-17	HUMAN PRESCRIPTION DRUG LABEL	100
Ciprofloxacin	Bryant Ranch Prepack	2021-02-17	HUMAN PRESCRIPTION DRUG LABEL	100