ciprofloxacin

Product NDC: 16571-413
11-digit product format: 165710413
Labeler code: 16571
Product ID: 16571-413_f031ce92-a4ed-45b0-8eb3-c3bdb02fbece
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ciprofloxacin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA076639
Marketing category: ANDA
Marketing start: 2004-09-10
Substance: CIPROFLOXACIN HYDROCHLORIDE
Active strength: 750 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

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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CIPROFLOXACIN HYDROCHLORIDE	750 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
ef468722-68cd-440b-afd7-2285029db41f	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
16571-413-05	ciprofloxacin	50 in 1 BOTTLE	TABLET, FILM COATED	50		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16571-413-05	EA - Each	16571-413	88dbcbda-2702-4cb3-a233-81740757eaaf	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ciprofloxacin hydrochloride	ACTIVE INGREDIENT	4BA73M5E37	CIPROFLOXACIN TABLET [RISING PHARMACEUTICALS, INC.]	3
CIPROFLOXACIN HYDROCHLORIDE	ACTIVE INGREDIENT	4BA73M5E37	CIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
CIPROFLOXACIN	ACTIVE MOIETY	5E8K9I0O4U	CIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
ciprofloxacin	ACTIVE MOIETY	5E8K9I0O4U	CIPROFLOXACIN TABLET [RISING PHARMACEUTICALS, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CIPROFLOXACIN TABLET [RISING PHARMACEUTICALS, INC.]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CIPROFLOXACIN TABLET [RISING PHARMACEUTICALS, INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CIPROFLOXACIN TABLET [RISING PHARMACEUTICALS, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CIPROFLOXACIN TABLET [RISING PHARMACEUTICALS, INC.]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CIPROFLOXACIN TABLET [RISING PHARMACEUTICALS, INC.]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CIPROFLOXACIN TABLET [RISING PHARMACEUTICALS, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CIPROFLOXACIN TABLET [RISING PHARMACEUTICALS, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CIPROFLOXACIN TABLET [RISING PHARMACEUTICALS, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	CIPROFLOXACIN TABLET [RISING PHARMACEUTICALS, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	CIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16571-413	CIPROFLOXACIN TABLET [RISING PHARMA HOLDINGS, INC.]	16	Current NDC, Legacy NDC, 1 package rows	20250502_ef468722-68cd-440b-afd7-2285029db41f.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 ndc (product): 16571-413
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	ef468722-68cd-440b-afd7-2285029db41f	18
309309	ciprofloxacin 500 MG Oral Tablet	PSN	ef468722-68cd-440b-afd7-2285029db41f	18
197512	ciprofloxacin 750 MG Oral Tablet	PSN	ef468722-68cd-440b-afd7-2285029db41f	18
197511	ciprofloxacin 250 MG Oral Tablet	SCD	ef468722-68cd-440b-afd7-2285029db41f	18
309309	ciprofloxacin 500 MG Oral Tablet	SCD	ef468722-68cd-440b-afd7-2285029db41f	18
197512	ciprofloxacin 750 MG Oral Tablet	SCD	ef468722-68cd-440b-afd7-2285029db41f	18
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	ef468722-68cd-440b-afd7-2285029db41f	18
197512	ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral Tablet	SY	ef468722-68cd-440b-afd7-2285029db41f	18
197511	ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral Tablet	SY	ef468722-68cd-440b-afd7-2285029db41f	18
197512	ciprofloxacin 750 MG Oral Tablet	PSN	2491e6a9-3415-43b9-b31b-67331f52806a	17
197512	ciprofloxacin 750 MG Oral Tablet	SCD	2491e6a9-3415-43b9-b31b-67331f52806a	17
197512	ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral Tablet	SY	2491e6a9-3415-43b9-b31b-67331f52806a	17
197512	ciprofloxacin 750 MG Oral Tablet	PSN	4af3894a-8945-4b2d-bdf6-a83bbd415b89	4
197512	ciprofloxacin 750 MG Oral Tablet	PSN	4fa9482a-ee88-1afd-e054-00144ff8d46c	4
197512	ciprofloxacin 750 MG Oral Tablet	SCD	4fa9482a-ee88-1afd-e054-00144ff8d46c	4
197512	ciprofloxacin 750 MG Oral Tablet	SCD	4af3894a-8945-4b2d-bdf6-a83bbd415b89	4
197512	ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral Tablet	SY	4fa9482a-ee88-1afd-e054-00144ff8d46c	4
197512	ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral Tablet	SY	4af3894a-8945-4b2d-bdf6-a83bbd415b89	4
197511	ciprofloxacin 250 MG Oral Tablet	PSN	d10f7c93-a08b-4e9c-bfa2-6646e3ea21bd	3
309309	ciprofloxacin 500 MG Oral Tablet	PSN	d10f7c93-a08b-4e9c-bfa2-6646e3ea21bd	3
197512	ciprofloxacin 750 MG Oral Tablet	PSN	d10f7c93-a08b-4e9c-bfa2-6646e3ea21bd	3
197511	ciprofloxacin 250 MG Oral Tablet	SCD	d10f7c93-a08b-4e9c-bfa2-6646e3ea21bd	3
309309	ciprofloxacin 500 MG Oral Tablet	SCD	d10f7c93-a08b-4e9c-bfa2-6646e3ea21bd	3
197512	ciprofloxacin 750 MG Oral Tablet	SCD	d10f7c93-a08b-4e9c-bfa2-6646e3ea21bd	3
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	d10f7c93-a08b-4e9c-bfa2-6646e3ea21bd	3
197512	ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral Tablet	SY	d10f7c93-a08b-4e9c-bfa2-6646e3ea21bd	3
197511	ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral Tablet	SY	d10f7c93-a08b-4e9c-bfa2-6646e3ea21bd	3
197512	ciprofloxacin 750 MG Oral Tablet	PSN	3c4fc96d-9017-5802-e054-00144ff88e88	2
197512	ciprofloxacin 750 MG Oral Tablet	SCD	3c4fc96d-9017-5802-e054-00144ff88e88	2
197512	ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral Tablet	SY	3c4fc96d-9017-5802-e054-00144ff88e88	2
197512	ciprofloxacin 750 MG Oral Tablet	PSN	9adbfd58-04d8-0e4b-e053-2995a90a86bd	1
197512	ciprofloxacin 750 MG Oral Tablet	PSN	2fff7a38-2c4e-d343-e063-6294a90aca3c	1
197512	ciprofloxacin 750 MG Oral Tablet	SCD	9adbfd58-04d8-0e4b-e053-2995a90a86bd	1
197512	ciprofloxacin 750 MG Oral Tablet	SCD	2fff7a38-2c4e-d343-e063-6294a90aca3c	1
197512	ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral Tablet	SY	2fff7a38-2c4e-d343-e063-6294a90aca3c	1
197512	ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral Tablet	SY	9adbfd58-04d8-0e4b-e053-2995a90a86bd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16571-413-05	16571041305	50 TABLET, FILM COATED in 1 BOTTLE (16571-413-05)		2004-09-10	0000-00-00	No	No	Current
16571-413-10	16571041310	100 TABLET in 1 BOTTLE (16571-413-10)	100 tablet	2004-09-10	0000-00-00	No	No	Current
16571-413-50	16571041350	500 TABLET in 1 BOTTLE (16571-413-50)	500 tablet	2004-09-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ciprofloxacin	Rising Pharma Holdings, Inc. \| Unique Pharmaceutical Laboratories	2025-07-18	Human Prescription Drug Label	18
ciprofloxacin	PD-Rx Pharmaceuticals, Inc.	2025-06-04	HUMAN PRESCRIPTION DRUG LABEL	17
ciprofloxacin	Coupler LLC \| Unique Pharmaceutical Laboratories	2025-03-10	HUMAN PRESCRIPTION DRUG LABEL	1
ciprofloxacin - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	4
ciprofloxacin	Proficient Rx LP	2020-02-01	HUMAN PRESCRIPTION DRUG LABEL	4
ciprofloxacin	Medsource Pharmaceuticals \| Unique Pharmaceutical Laboratories	2019-12-29	HUMAN PRESCRIPTION DRUG LABEL	1
CIPROFLOXACIN	DIRECT RX	2016-10-04	HUMAN PRESCRIPTION DRUG LABEL	2
Ciprofloxacin Tablets 250 mg, 500 mg and 750 mg	Aidarex Pharmaceuticals LLC	2012-09-14	HUMAN PRESCRIPTION DRUG LABEL	3