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

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 Identifiers#

Field, Values table
Field	Values
Unii	4BA73M5E37
Rxcui	197511, 197512, 309309

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

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

ciprofloxacin

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#