Ciprofloxacin

Product NDC: 16252-516
Requested package NDC: 16252-516-05
11-digit product format: 162520516
Labeler code: 16252
Product ID: 16252-516_ca204c4b-0e44-47d0-9fe0-6947a714315d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ciprofloxacin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA076794
Marketing category: ANDA
Marketing start: 2006-11-01
Marketing end: 0000-00-00
Substance: CIPROFLOXACIN HYDROCHLORIDE
Active strength: 750 mg/1
Pharmacologic classes: Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	16252-516	16252-516-05	D	Discontinued by firm		2026-08-11

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…`

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
16252-516-05	Ciprofloxacin	50 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	50		36

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16252-516-05	EA - Each	16252-516	617622d4-e222-48df-80a2-b7f6e8961ac5	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, FILM COATED [ACTAVIS PHARMA, INC.]	17
CIPROFLOXACIN	ACTIVE MOIETY	5E8K9I0O4U	CIPROFLOXACIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	17
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CIPROFLOXACIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	17
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CIPROFLOXACIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	17
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CIPROFLOXACIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	17
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CIPROFLOXACIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	17
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	CIPROFLOXACIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	17
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CIPROFLOXACIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	17
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CIPROFLOXACIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	17
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CIPROFLOXACIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	17
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CIPROFLOXACIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	17
WATER	INACTIVE INGREDIENT	059QF0KO0R	CIPROFLOXACIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	17
ciprofloxacin hydrochloride	ACTIVE INGREDIENT	4BA73M5E37	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	6
ciprofloxacin	ACTIVE MOIETY	5E8K9I0O4U	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	6
crospovidone	INACTIVE INGREDIENT	68401960MK	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	6
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	6
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	6
polyvinyl alcohol	INACTIVE INGREDIENT	532B59J990	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	6
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	6
talc	INACTIVE INGREDIENT	7SEV7J4R1U	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	6
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	6
ciprofloxacin hydrochloride	ACTIVE INGREDIENT	4BA73M5E37	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
ciprofloxacin	ACTIVE MOIETY	5E8K9I0O4U	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
crospovidone	INACTIVE INGREDIENT	68401960MK	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
polyvinyl alcohol	INACTIVE INGREDIENT	532B59J990	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
talc	INACTIVE INGREDIENT	7SEV7J4R1U	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16252-516	CIPROFLOXACIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]	36	Legacy NDC, 1 package rows	20250410_3e4402d4-e0d3-9846-3e81-ed46f34137fe.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 ndc (package): 16252-516-05 ndc (product): 16252-516 ndc11 (package): 16252051605
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

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	3e4402d4-e0d3-9846-3e81-ed46f34137fe	36
309309	ciprofloxacin 500 MG Oral Tablet	PSN	3e4402d4-e0d3-9846-3e81-ed46f34137fe	36
197512	ciprofloxacin 750 MG Oral Tablet	PSN	3e4402d4-e0d3-9846-3e81-ed46f34137fe	36
197511	ciprofloxacin 250 MG Oral Tablet	SCD	3e4402d4-e0d3-9846-3e81-ed46f34137fe	36
309309	ciprofloxacin 500 MG Oral Tablet	SCD	3e4402d4-e0d3-9846-3e81-ed46f34137fe	36
197512	ciprofloxacin 750 MG Oral Tablet	SCD	3e4402d4-e0d3-9846-3e81-ed46f34137fe	36
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	3e4402d4-e0d3-9846-3e81-ed46f34137fe	36
197512	ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral Tablet	SY	3e4402d4-e0d3-9846-3e81-ed46f34137fe	36
197511	ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral Tablet	SY	3e4402d4-e0d3-9846-3e81-ed46f34137fe	36
197511	ciprofloxacin 250 MG Oral Tablet	PSN	64d0b20a-cecd-474e-a0a1-8f8853500def	6
309309	ciprofloxacin 500 MG Oral Tablet	PSN	64d0b20a-cecd-474e-a0a1-8f8853500def	6
197512	ciprofloxacin 750 MG Oral Tablet	PSN	64d0b20a-cecd-474e-a0a1-8f8853500def	6
197511	ciprofloxacin 250 MG Oral Tablet	SCD	64d0b20a-cecd-474e-a0a1-8f8853500def	6
309309	ciprofloxacin 500 MG Oral Tablet	SCD	64d0b20a-cecd-474e-a0a1-8f8853500def	6
197512	ciprofloxacin 750 MG Oral Tablet	SCD	64d0b20a-cecd-474e-a0a1-8f8853500def	6
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	64d0b20a-cecd-474e-a0a1-8f8853500def	6
197512	ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral Tablet	SY	64d0b20a-cecd-474e-a0a1-8f8853500def	6
197511	ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral Tablet	SY	64d0b20a-cecd-474e-a0a1-8f8853500def	6
197512	ciprofloxacin 750 MG Oral Tablet	PSN	e659af2b-b240-4afe-894e-962ae9c3d87f	3
197512	ciprofloxacin 750 MG Oral Tablet	SCD	e659af2b-b240-4afe-894e-962ae9c3d87f	3
197512	ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral Tablet	SY	e659af2b-b240-4afe-894e-962ae9c3d87f	3
197511	ciprofloxacin 250 MG Oral Tablet	PSN	99a81fda-81dc-40b3-b55a-165b6e4ca4ee	2
309309	ciprofloxacin 500 MG Oral Tablet	PSN	99a81fda-81dc-40b3-b55a-165b6e4ca4ee	2
197512	ciprofloxacin 750 MG Oral Tablet	PSN	99a81fda-81dc-40b3-b55a-165b6e4ca4ee	2
197511	ciprofloxacin 250 MG Oral Tablet	SCD	99a81fda-81dc-40b3-b55a-165b6e4ca4ee	2
309309	ciprofloxacin 500 MG Oral Tablet	SCD	99a81fda-81dc-40b3-b55a-165b6e4ca4ee	2
197512	ciprofloxacin 750 MG Oral Tablet	SCD	99a81fda-81dc-40b3-b55a-165b6e4ca4ee	2
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	99a81fda-81dc-40b3-b55a-165b6e4ca4ee	2
197512	ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral Tablet	SY	99a81fda-81dc-40b3-b55a-165b6e4ca4ee	2
197511	ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral Tablet	SY	99a81fda-81dc-40b3-b55a-165b6e4ca4ee	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16252-516-05	16252051605	50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16252-516-05)	2006-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ciprofloxacin	Teva Pharmaceuticals USA, Inc.	2024-10-30	HUMAN PRESCRIPTION DRUG LABEL	36
Ciprofloxacin	Bryant Ranch Prepack	2022-05-02	HUMAN PRESCRIPTION DRUG LABEL	3
CIPROFLOXACIN TABLETS, USP	Physicians Total Care, Inc.	2012-09-14	HUMAN PRESCRIPTION DRUG LABEL	6
CIPROFLOXACIN TABLETS, USP	H.J. Harkins Company, Inc. \| Cobalt Laboratories Inc. \| Cobalt Pharmaceuticals \| Arrow Pharm (Malta) Ltd.	2011-11-30	HUMAN PRESCRIPTION DRUG LABEL	2