Ciprofloxacin

Product NDC: 85534-0069
11-digit product format: 855340069
Labeler code: 85534
Product ID: 85534-0069_56776b15-35d3-3952-e063-6294a90a91e6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ciprofloxacin Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: HAWAII REPACK, INC.
Application: ANDA077859
Marketing category: ANDA
Marketing start: 2007-04-26
Marketing end: 2027-01-31
Substance: CIPROFLOXACIN HYDROCHLORIDE
Active strength: 250 mg/1
Pharmacologic classes: Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag: No
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077859-001	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-26
A077859-002	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-26
A077859-003	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2007-04-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077859-001	AB
A077859-002	AB
A077859-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A077859-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077859-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077859-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2007-04-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077859-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077859-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077859-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2007-04-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077859-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077859-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077859-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2007-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077859-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077859-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077859-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2007-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077859-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077859-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077859-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2007-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077859-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077859-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077859-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2007-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077859-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077859-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077859-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2007-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077859-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077859-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077859-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2007-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077859-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077859-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077859-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2007-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077859-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077859-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077859-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2007-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077859-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077859-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077859-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2007-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077859-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077859-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077859-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2007-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077859-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077859-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077859-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2007-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077859-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-26	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077859-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077859-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077859-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077859-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077859-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077859-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077859-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077859-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077859-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077859-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077859-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077859-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077859-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077859-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077859-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077859-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077859-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077859-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077859-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077859-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077859-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077859-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077859-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077859-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077859-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077859-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077859-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077859-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077859-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077859-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077859-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077859-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077859-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077859-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077859-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077859-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077859-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077859-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077859-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077859-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Ciprofloxacin

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CIPROFLOXACIN HYDROCHLORIDE	250 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197511	Internal RxNorm lookup
197512	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
0fe3becb-f90e-4187-a8e8-bd0de5a79ad2	Available on FDA.report

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 2 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	3c611c8c-deed-4904-93f7-f75a2147fbf7	2025-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077859 application number: ANDA077859
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Aurobindo Pharma Limited	7041828f-d4ec-4813-bcac-cb335c6c312a	2025-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077859 application number: ANDA077859
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Aurobindo Pharma Limited	2b3b6a9f-259c-4736-b88f-f49d1eb64286	2025-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077859 application number: ANDA077859
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	A-S Medication Solutions	cc768d3e-a7cc-46a2-ae6d-0f5eb2f05406	2025-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077859 application number: ANDA077859
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	1cb05412-372e-4b49-92e1-532caa05f38f	2025-02-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077859 application number: ANDA077859
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Proficient Rx LP	ec337816-4f48-4d04-b91d-60f9f5f634da	2024-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077859 application number: ANDA077859
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Proficient Rx LP	9ee1f252-a64e-4b72-a6f7-60298e827222	2022-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077859 application number: ANDA077859
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4e74496f-4dca-4471-be32-c0a14bc62750	2018-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077859 application number: ANDA077859

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4BA73M5E37	CIPROFLOXACIN HYDROCHLORIDE	86393-32-0	CIPROFLOXACIN HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
85534-0069-0	85534006900	6 TABLET, FILM COATED in 1 BOTTLE (85534-0069-0)	2026-07-13	2027-01-31	No	No	Historical
85534-0069-1	85534006901	10 TABLET, FILM COATED in 1 BOTTLE (85534-0069-1)	2026-07-13	2027-01-31	No	No	Historical
85534-0069-2	85534006902	14 TABLET, FILM COATED in 1 BOTTLE (85534-0069-2)	2026-07-13	2027-01-31	No	No	Historical
85534-0069-3	85534006903	20 TABLET, FILM COATED in 1 BOTTLE (85534-0069-3)	2026-07-13	2027-01-31	No	No	Historical
85534-0069-4	85534006904	21 TABLET, FILM COATED in 1 BOTTLE (85534-0069-4)	2026-07-13	2027-01-31	No	No	Historical
85534-0069-5	85534006905	28 TABLET, FILM COATED in 1 BOTTLE (85534-0069-5)	2026-07-13	2027-01-31	No	No	Historical
85534-0069-6	85534006906	30 TABLET, FILM COATED in 1 BOTTLE (85534-0069-6)	2026-07-13	2027-01-31	No	No	Historical