ciprofloxacin

Product NDC: 53002-2640
Requested package NDC: 53002-2640-9
11-digit product format: 530022640
Labeler code: 53002
Product ID: 53002-2640_b2746be2-3d99-4c4c-a4d0-042734aae2a3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ciprofloxacin
Dosage form: TABLET
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA076639
Marketing category: ANDA
Marketing start: 2004-09-10
Marketing end: 0000-00-00
Substance: CIPROFLOXACIN HYDROCHLORIDE
Active strength: 500 mg/1
Pharmacologic classes: Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53002-2640	53002-2640-9	I	Inactivated by FDA		2026-08-10

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 · 11 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2020-12-18 03:04 UTC · source 2020-12-17	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A076639-001	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-09-10
A076639-002	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-09-10
A076639-003	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-09-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A076639-001	AB
A076639-002	AB
A076639-003	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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	A076639-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076639-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076639-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076639-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076639-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076639-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076639-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076639-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076639-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076639-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076639-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076639-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076639-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076639-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076639-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076639-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076639-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076639-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076639-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076639-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076639-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076639-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076639-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076639-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076639-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-09-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076639-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-09-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076639-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076639-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-09-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076639-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-09-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076639-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076639-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-09-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076639-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-09-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076639-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076639-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-09-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076639-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-09-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076639-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-09-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076639-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-09-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076639-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-09-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076639-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-09-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076639-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-09-10	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076639-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076639-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076639-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076639-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076639-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076639-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076639-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076639-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076639-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076639-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076639-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076639-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076639-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076639-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076639-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076639-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076639-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076639-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076639-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076639-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076639-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076639-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076639-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076639-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076639-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076639-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076639-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076639-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076639-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076639-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076639-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076639-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076639-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076639-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076639-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076639-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076639-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076639-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076639-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076639-001	AB	1	`8072bd15b7f6…`

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, Effective, Related label table
NDC	Effective	Related label
53002-2640-0	2025-01-30	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-1	2025-01-30	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-2	2025-01-30	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-3	2025-01-30	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-4	2025-01-30	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-5	2025-01-30	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-6	2025-01-30	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-9	2025-01-30	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-0	2023-06-07	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-1	2023-06-07	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-2	2023-06-07	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-3	2023-06-07	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-4	2023-06-07	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-5	2023-06-07	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-6	2023-06-07	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-9	2023-06-07	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-0	2023-01-30	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-1	2023-01-30	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-2	2023-01-30	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-3	2023-01-30	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-4	2023-01-30	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-5	2023-01-30	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-6	2023-01-30	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-9	2023-01-30	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-0	2020-12-15	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-1	2020-12-15	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-2	2020-12-15	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-3	2020-12-15	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-4	2020-12-15	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-5	2020-12-15	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-6	2020-12-15	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-9	2020-12-15	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-0	2020-01-31	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-1	2020-01-31	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-2	2020-01-31	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-3	2020-01-31	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-4	2020-01-31	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-5	2020-01-31	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-6	2020-01-31	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
53002-2640-9	2020-01-31	These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53002-2640-0	ciprofloxacin	30 in 1 BOTTLE	TABLET	30	10
53002-2640-1	ciprofloxacin	1 in 1 BOTTLE	TABLET	1	10
53002-2640-2	ciprofloxacin	6 in 1 BOTTLE	TABLET	6	10
53002-2640-3	ciprofloxacin	10 in 1 BOTTLE	TABLET	10	10
53002-2640-4	ciprofloxacin	14 in 1 BOTTLE	TABLET	14	10
53002-2640-5	ciprofloxacin	18 in 1 BOTTLE	TABLET	18	10
53002-2640-6	ciprofloxacin	20 in 1 BOTTLE	TABLET	20	10
53002-2640-9	ciprofloxacin	28 in 1 BOTTLE	TABLET	28	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-2640	CIPROFLOXACIN TABLET [RPK PHARMACEUTICALS, INC.]	10	Legacy NDC, 8 package rows	20230609_23dbc8a8-556c-40a5-a3fe-cd1f32300402.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ciprofloxacin	CIPROFLOXACIN	Northwind Health Company, LLC	4deea61e-f3ca-b35d-e063-6294a90a9d41	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076639 application number: ANDA076639
ciprofloxacin	CIPROFLOXACIN	Cardinal Health 107, LLC	922e9f5c-cc59-4d9e-bf42-a4b900d077ed	2026-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076639 application number: ANDA076639
ciprofloxacin	CIPROFLOXACIN	Major Pharmaceuticals	f818ed31-c746-4171-afdf-57a75434e5f1	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076639 application number: ANDA076639
ciprofloxacin	CIPROFLOXACIN	QPharma, Inc.	4149d980-a6cd-c06d-e063-6394a90a47a1	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076639 application number: ANDA076639
ciprofloxacin	CIPROFLOXACIN	Rising Pharma Holdings, Inc.	ef468722-68cd-440b-afd7-2285029db41f	2025-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076639 application number: ANDA076639
ciprofloxacin	CIPROFLOXACIN	PD-Rx Pharmaceuticals, Inc.	2491e6a9-3415-43b9-b31b-67331f52806a	2025-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076639 application number: ANDA076639
ciprofloxacin	CIPROFLOXACIN	PD-Rx Pharmaceuticals, Inc.	e81341c6-0e25-4860-adda-2d3cebe88d62	2025-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076639 application number: ANDA076639
ciprofloxacin	CIPROFLOXACIN	PD-Rx Pharmaceuticals, Inc.	178dc379-e2b8-4b47-9f0c-3fc7fb435c36	2025-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076639 application number: ANDA076639
ciprofloxacin	CIPROFLOXACIN	A-S Medication Solutions	c12b316f-811c-48b6-a320-d314991aa74f	2025-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076639 application number: ANDA076639
ciprofloxacin	CIPROFLOXACIN	Bryant Ranch Prepack	69df48cc-76b6-428e-891a-c25e07d785f8	2025-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076639 application number: ANDA076639
ciprofloxacin	CIPROFLOXACIN	Bryant Ranch Prepack	a5ecc693-b8fd-4a7a-8040-e56f801c9353	2025-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076639 application number: ANDA076639
ciprofloxacin	CIPROFLOXACIN	Coupler LLC	2fff7a38-2c4e-d343-e063-6294a90aca3c	2025-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076639 application number: ANDA076639
ciprofloxacin	CIPROFLOXACIN	Umasuto, LLC	0c355077-7361-41d0-9e82-eb31beaf5daa	2025-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076639 application number: ANDA076639
ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals, Inc.	44e5582d-fff1-0ec9-e054-00144ff88e88	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076639 application number: ANDA076639
ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals, Inc.	46dedf2c-26de-0f46-e054-00144ff88e88	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076639 application number: ANDA076639
ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals,Inc.	641729a3-6dd3-3a2f-e053-2991aa0a015e	2024-06-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076639 application number: ANDA076639
ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals,Inc.	5bab9397-b9f3-d309-e053-2991aa0a6612	2024-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076639 application number: ANDA076639
ciprofloxacin	CIPROFLOXACIN	A-S Medication Solutions	6971a958-08f0-4712-bf5f-47fe4f76b863	2023-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076639 application number: ANDA076639
ciprofloxacin	CIPROFLOXACIN	PharmPak, Inc.	e2902d14-16bb-46a9-a45a-4f1f9b0ecf4a	2022-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076639 application number: ANDA076639
ciprofloxacin	CIPROFLOXACIN	PharmPak, Inc.	6a70db6c-ae68-49e5-8a4a-b5cd1d4840bd	2022-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076639 application number: ANDA076639

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
197511	ciprofloxacin 250 MG Oral Tablet	PSN	23dbc8a8-556c-40a5-a3fe-cd1f32300402	10
309309	ciprofloxacin 500 MG Oral Tablet	PSN	23dbc8a8-556c-40a5-a3fe-cd1f32300402	10
197511	ciprofloxacin 250 MG Oral Tablet	SCD	23dbc8a8-556c-40a5-a3fe-cd1f32300402	10
309309	ciprofloxacin 500 MG Oral Tablet	SCD	23dbc8a8-556c-40a5-a3fe-cd1f32300402	10
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	23dbc8a8-556c-40a5-a3fe-cd1f32300402	10
197511	ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral Tablet	SY	23dbc8a8-556c-40a5-a3fe-cd1f32300402	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-2640-9	53002264009	28 TABLET in 1 BOTTLE (53002-2640-9)	28 tablet	2017-10-01	0000-00-00	No	No	Current