Ciprofloxacin

Product NDC: 68071-2269
11-digit product format: 680712269
Labeler code: 68071
Product ID: 68071-2269_1d768e94-f620-944b-e063-6294a90a9549
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ciprofloxacin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA076794
Marketing category: ANDA
Marketing start: 2006-11-01
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

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 · 4 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
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68071-2269-4	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68071-2269-4	`bd6a592717d7…`	`303034d00443…`

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
A076794-002	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09
A076794-003	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09
A076794-004	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076794-002	AB
A076794-003	AB
A076794-004	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 · 153 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	A076794-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076794-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076794-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076794-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076794-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076794-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076794-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076794-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076794-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076794-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076794-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076794-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076794-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076794-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076794-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076794-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076794-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076794-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076794-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076794-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076794-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076794-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076794-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076794-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076794-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076794-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076794-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076794-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076794-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076794-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076794-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL		2005-02-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076794-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076794-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076794-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076794-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL		2005-02-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076794-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076794-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076794-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076794-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL		2005-02-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076794-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 147 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	A076794-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076794-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076794-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076794-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076794-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076794-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076794-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076794-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076794-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076794-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076794-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076794-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076794-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076794-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076794-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076794-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076794-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076794-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076794-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076794-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076794-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076794-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076794-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076794-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076794-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076794-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076794-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076794-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076794-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076794-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076794-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076794-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076794-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076794-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076794-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076794-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076794-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076794-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076794-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076794-002	AB	1	`8072bd15b7f6…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
b064286b-fedc-be68-e053-2995a90aae52	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2269-4	2022-05-24	C162847	48780-1	d6a99b39-61e6-a426-e053-dadaa90af4c2	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 s , for oral use Initial U.S. Approval: 1987
68071-2269-4	2022-01-28	C162847	48780-1	d6a99b39-61e6-a426-e053-dadaa90af4c2	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 s , for oral use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2269-4	Ciprofloxacin	4 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	4		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2269	CIPROFLOXACIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	3	Current NDC, Legacy NDC, 1 package rows	20240719_b064286b-fedc-be68-e053-2995a90aae52.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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ciprofloxacin	CIPROFLOXACIN	Teva Pharmaceuticals USA, Inc.	3e4402d4-e0d3-9846-3e81-ed46f34137fe	2024-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076794 application number: ANDA076794
Ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals,Inc.	b0136d72-0869-2da0-e053-2995a90af70a	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076794 application number: ANDA076794
Ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals,Inc.	b064286b-fedc-be68-e053-2995a90aae52	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076794 application number: ANDA076794 ndc (product): 68071-2269

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	b064286b-fedc-be68-e053-2995a90aae52	3
309309	ciprofloxacin 500 MG Oral Tablet	SCD	b064286b-fedc-be68-e053-2995a90aae52	3
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	b064286b-fedc-be68-e053-2995a90aae52	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2269-4	68071226904	4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68071-2269-4)	2020-09-28	0000-00-00	No	No	Current