Ciprofloxacin

Product NDC: 65862-077
Requested package NDC: 65862-077-01
11-digit product format: 658620077
Labeler code: 65862
Product ID: 65862-077_9e7eb1ac-3e09-4b4c-8ce1-ab16c3102a10
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ciprofloxacin Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA077859
Marketing category: ANDA
Marketing start: 2007-04-26
Marketing end: 2027-02-28
Substance: CIPROFLOXACIN HYDROCHLORIDE
Active strength: 500 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 44.

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 · 132 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
2026-10-15 13:18:30	2026-09	A077859-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077859-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077859-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2007-04-26	`c2088c7a36db…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A077859-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077859-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077859-003	AB	1	`c2088c7a36db…`
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…`

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	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 · 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
2b3b6a9f-259c-4736-b88f-f49d1eb64286	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	SPL version
65862-077-01	Ciprofloxacin	100 in 1 BOTTLE	TABLET, FILM COATED	100	33
65862-077-05	Ciprofloxacin	500 in 1 BOTTLE	TABLET, FILM COATED	500	33
65862-077-20	Ciprofloxacin	20 in 1 BOTTLE	TABLET, FILM COATED	20	33
65862-077-30	Ciprofloxacin	30 in 1 BOTTLE	TABLET, FILM COATED	30	33
65862-077-99	Ciprofloxacin	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-077-01	EA - Each	65862-077	4c5116a1-ac78-42ce-afe6-94318a4676d8	1	2012-07-24
65862-077-05	EA - Each	65862-077	29b51b15-5176-4c00-8aff-f49fd56b31fc	1	2021-11-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CIPROFLOXACIN HYDROCHLORIDE	ACTIVE INGREDIENT	4BA73M5E37	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	14
CIPROFLOXACIN	ACTIVE MOIETY	5E8K9I0O4U	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	14
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	14
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	14
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	14
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	14
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	14
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	14
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	14
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-077	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	32	Current NDC, Legacy NDC, 5 package rows	20250501_2b3b6a9f-259c-4736-b88f-f49d1eb64286.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 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 ndc (package): 65862-077-01 ndc (product): 65862-077 ndc11 (package): 65862007701
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309309	ciprofloxacin 500 MG Oral Tablet	PSN	ac87e3c7-1e51-4dd1-8b75-dec6536810e3	104
309309	ciprofloxacin 500 MG Oral Tablet	SCD	ac87e3c7-1e51-4dd1-8b75-dec6536810e3	104
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	ac87e3c7-1e51-4dd1-8b75-dec6536810e3	104
309309	ciprofloxacin 500 MG Oral Tablet	PSN	a2ffa81a-86c5-40b9-8fa0-c889801ef479	38
309309	ciprofloxacin 500 MG Oral Tablet	SCD	a2ffa81a-86c5-40b9-8fa0-c889801ef479	38
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	a2ffa81a-86c5-40b9-8fa0-c889801ef479	38
309309	ciprofloxacin 500 MG Oral Tablet	PSN	d290a840-6c60-435f-a46b-6d9ef7b9e5f3	34
309309	ciprofloxacin 500 MG Oral Tablet	SCD	d290a840-6c60-435f-a46b-6d9ef7b9e5f3	34
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	d290a840-6c60-435f-a46b-6d9ef7b9e5f3	34
197511	ciprofloxacin 250 MG Oral Tablet	PSN	2b3b6a9f-259c-4736-b88f-f49d1eb64286	33
309309	ciprofloxacin 500 MG Oral Tablet	PSN	2b3b6a9f-259c-4736-b88f-f49d1eb64286	33
197512	ciprofloxacin 750 MG Oral Tablet	PSN	2b3b6a9f-259c-4736-b88f-f49d1eb64286	33
197511	ciprofloxacin 250 MG Oral Tablet	SCD	2b3b6a9f-259c-4736-b88f-f49d1eb64286	33
309309	ciprofloxacin 500 MG Oral Tablet	SCD	2b3b6a9f-259c-4736-b88f-f49d1eb64286	33
197512	ciprofloxacin 750 MG Oral Tablet	SCD	2b3b6a9f-259c-4736-b88f-f49d1eb64286	33
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	2b3b6a9f-259c-4736-b88f-f49d1eb64286	33
197512	ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral Tablet	SY	2b3b6a9f-259c-4736-b88f-f49d1eb64286	33
197511	ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral Tablet	SY	2b3b6a9f-259c-4736-b88f-f49d1eb64286	33
309309	ciprofloxacin 500 MG Oral Tablet	PSN	9d83b127-ef13-4b2c-aa30-0f54937dc240	18
309309	ciprofloxacin 500 MG Oral Tablet	SCD	9d83b127-ef13-4b2c-aa30-0f54937dc240	18
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	9d83b127-ef13-4b2c-aa30-0f54937dc240	18
309309	ciprofloxacin 500 MG Oral Tablet	PSN	4d5afeff-3917-43e1-9d12-d70ccab00dcc	11
309309	ciprofloxacin 500 MG Oral Tablet	SCD	4d5afeff-3917-43e1-9d12-d70ccab00dcc	11
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	4d5afeff-3917-43e1-9d12-d70ccab00dcc	11
309309	ciprofloxacin 500 MG Oral Tablet	PSN	d8b21832-b74f-4f85-a304-b907c9e01e72	10
309309	ciprofloxacin 500 MG Oral Tablet	SCD	d8b21832-b74f-4f85-a304-b907c9e01e72	10
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	d8b21832-b74f-4f85-a304-b907c9e01e72	10
309309	ciprofloxacin 500 MG Oral Tablet	PSN	a7e5174a-dd01-6050-e053-2a95a90add3f	7
309309	ciprofloxacin 500 MG Oral Tablet	PSN	76dedf59-46be-1be0-e053-2991aa0a1c36	7
309309	ciprofloxacin 500 MG Oral Tablet	SCD	76dedf59-46be-1be0-e053-2991aa0a1c36	7
309309	ciprofloxacin 500 MG Oral Tablet	SCD	a7e5174a-dd01-6050-e053-2a95a90add3f	7
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	76dedf59-46be-1be0-e053-2991aa0a1c36	7
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	a7e5174a-dd01-6050-e053-2a95a90add3f	7
309309	ciprofloxacin 500 MG Oral Tablet	PSN	7a7cc017-fc08-3118-e053-2991aa0ad7af	5
309309	ciprofloxacin 500 MG Oral Tablet	PSN	e237dd23-faf3-1765-e053-2a95a90ae62d	5
309309	ciprofloxacin 500 MG Oral Tablet	PSN	f80ab01d-2533-1b4c-e053-6294a90a6e6a	5
309309	ciprofloxacin 500 MG Oral Tablet	SCD	f80ab01d-2533-1b4c-e053-6294a90a6e6a	5
309309	ciprofloxacin 500 MG Oral Tablet	SCD	e237dd23-faf3-1765-e053-2a95a90ae62d	5
309309	ciprofloxacin 500 MG Oral Tablet	SCD	7a7cc017-fc08-3118-e053-2991aa0ad7af	5
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	7a7cc017-fc08-3118-e053-2991aa0ad7af	5
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	e237dd23-faf3-1765-e053-2a95a90ae62d	5
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	f80ab01d-2533-1b4c-e053-6294a90a6e6a	5
309309	ciprofloxacin 500 MG Oral Tablet	PSN	1cb05412-372e-4b49-92e1-532caa05f38f	4
309309	ciprofloxacin 500 MG Oral Tablet	PSN	ec337816-4f48-4d04-b91d-60f9f5f634da	4
309309	ciprofloxacin 500 MG Oral Tablet	PSN	4fe686e7-b9bb-7450-e054-00144ff8d46c	4
309309	ciprofloxacin 500 MG Oral Tablet	SCD	1cb05412-372e-4b49-92e1-532caa05f38f	4
309309	ciprofloxacin 500 MG Oral Tablet	SCD	ec337816-4f48-4d04-b91d-60f9f5f634da	4
309309	ciprofloxacin 500 MG Oral Tablet	SCD	4fe686e7-b9bb-7450-e054-00144ff8d46c	4
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	4fe686e7-b9bb-7450-e054-00144ff8d46c	4
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	1cb05412-372e-4b49-92e1-532caa05f38f	4
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	ec337816-4f48-4d04-b91d-60f9f5f634da	4
309309	ciprofloxacin 500 MG Oral Tablet	PSN	f2937a87-2e10-3728-e053-2a95a90a9eb9	3
309309	ciprofloxacin 500 MG Oral Tablet	SCD	f2937a87-2e10-3728-e053-2a95a90a9eb9	3
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	f2937a87-2e10-3728-e053-2a95a90a9eb9	3
309309	ciprofloxacin 500 MG Oral Tablet	PSN	d40f0560-fc57-4f00-9f6d-ae7e2a274330	2
309309	ciprofloxacin 500 MG Oral Tablet	PSN	da86ea21-084a-4a78-94fb-840391e5f1f6	2
309309	ciprofloxacin 500 MG Oral Tablet	PSN	b4c17302-590f-4de0-ad57-8bb050d9aa8a	2
309309	ciprofloxacin 500 MG Oral Tablet	PSN	ae77a5c0-a2ae-770c-e053-2a95a90a6a96	2
309309	ciprofloxacin 500 MG Oral Tablet	SCD	ae77a5c0-a2ae-770c-e053-2a95a90a6a96	2
309309	ciprofloxacin 500 MG Oral Tablet	SCD	da86ea21-084a-4a78-94fb-840391e5f1f6	2
309309	ciprofloxacin 500 MG Oral Tablet	SCD	d40f0560-fc57-4f00-9f6d-ae7e2a274330	2
309309	ciprofloxacin 500 MG Oral Tablet	SCD	b4c17302-590f-4de0-ad57-8bb050d9aa8a	2
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	da86ea21-084a-4a78-94fb-840391e5f1f6	2
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	d40f0560-fc57-4f00-9f6d-ae7e2a274330	2
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	b4c17302-590f-4de0-ad57-8bb050d9aa8a	2
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	ae77a5c0-a2ae-770c-e053-2a95a90a6a96	2
309309	ciprofloxacin 500 MG Oral Tablet	PSN	4e74496f-4dca-4471-be32-c0a14bc62750	1
309309	ciprofloxacin 500 MG Oral Tablet	SCD	4e74496f-4dca-4471-be32-c0a14bc62750	1
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	4e74496f-4dca-4471-be32-c0a14bc62750	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-077-01	65862007701	100 TABLET, FILM COATED in 1 BOTTLE (65862-077-01)	2007-04-26	2027-02-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ciprofloxacin	HAWAII REPACK, INC.	2026-07-13	HUMAN PRESCRIPTION DRUG LABEL	1
Ciprofloxacin	PD-Rx Pharmaceuticals, Inc.	2026-06-09	HUMAN PRESCRIPTION DRUG LABEL	39
Ciprofloxacin	Medsource Pharmaceuticals \| Aurobindo Pharma Limited	2026-05-13	HUMAN PRESCRIPTION DRUG LABEL	2
Ciprofloxacin	A-S Medication Solutions	2026-05-05	Human Prescription Drug Label	18
Ciprofloxacin	A-S Medication Solutions	2026-05-05	Human Prescription Drug Label	10
Ciprofloxacin HCL Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2026-04-29	HUMAN PRESCRIPTION DRUG LABEL	5
Ciprofloxacin	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2026-04-29	HUMAN PRESCRIPTION DRUG LABEL	2
CIPROFLOXACIN	DIRECT RX	2026-03-05	HUMAN PRESCRIPTION DRUG LABEL	7
Ciprofloxacin	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	5
Ciprofloxacin	QPharma Inc \| Aurobindo Pharma Limited \| Northwind Health Company, LLC	2025-12-11	HUMAN PRESCRIPTION DRUG LABEL	11
Ciprofloxacin	Bryant Ranch Prepack	2025-10-07	HUMAN PRESCRIPTION DRUG LABEL	104
Ciprofloxacin	PD-Rx Pharmaceuticals, Inc.	2025-08-22	HUMAN PRESCRIPTION DRUG LABEL	34
Ciprofloxacin	Aurobindo Pharma Limited	2025-07-28	Human Prescription Drug Label	33
Ciprofloxacin	Preferred Pharmaceuticals Inc.	2025-02-28	HUMAN PRESCRIPTION DRUG LABEL	4
Ciprofloxacin	REMEDYREPACK INC.	2025-02-19	HUMAN PRESCRIPTION DRUG LABEL	24
Ciprofloxacin	NCS HealthCare of KY, LLC dba Vangard Labs	2024-08-12	HUMAN PRESCRIPTION DRUG LABEL	4
Ciprofloxacin - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2024-07-17	HUMAN PRESCRIPTION DRUG LABEL	4
Ciprofloxacin	NuCare Pharmaceuticals,Inc.	2024-06-12	HUMAN PRESCRIPTION DRUG LABEL	7
Ciprofloxacin	NuCare Pharmaceuticals,Inc.	2024-06-12	HUMAN PRESCRIPTION DRUG LABEL	5
Ciprofloxacin	Proficient Rx LP	2024-06-01	HUMAN PRESCRIPTION DRUG LABEL	4
Ciprofloxacin - Pharmasource Meds, LLC	Pharmasource Meds, LLC	2024-05-28	HUMAN PRESCRIPTION DRUG LABEL	3
Ciprofloxacin	RPK Pharmaceuticals, Inc.	2023-08-07	Human Prescription Drug Label	2
Ciprofloxacin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	5