Ciprofloxacin

Product NDC: 63629-3868
11-digit product format: 636293868
Labeler code: 63629
Product ID: 63629-3868_8dabad3c-3808-45cc-a58d-127e3a3d6d6b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ciprofloxacin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA076558
Marketing category: ANDA
Marketing start: 2004-06-09
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	Approval date
A076558-002	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2004-06-09
A076558-003	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2004-06-09
A076558-004	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	2004-06-09

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	A076558-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076558-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076558-004	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	A076558-002	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	A076558-003	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	A076558-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076558-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076558-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076558-004	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	A076558-002	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	A076558-003	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	A076558-004	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	A076558-002	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	A076558-003	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	A076558-004	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	A076558-002	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	A076558-003	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	A076558-004	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	A076558-002	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	A076558-003	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	A076558-004	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	A076558-002	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	A076558-003	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	A076558-004	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	A076558-002	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	A076558-003	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	A076558-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076558-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076558-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076558-004	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	A076558-002	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	A076558-003	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	A076558-004	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	A076558-002	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	A076558-003	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	A076558-004	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	A076558-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076558-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076558-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076558-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 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	A076558-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076558-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076558-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076558-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076558-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076558-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076558-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076558-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076558-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076558-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076558-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076558-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076558-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076558-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076558-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076558-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076558-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076558-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076558-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076558-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076558-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076558-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076558-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076558-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076558-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076558-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076558-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076558-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076558-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076558-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076558-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076558-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076558-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076558-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076558-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076558-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076558-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076558-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076558-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076558-002	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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197512	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
a57066d7-dc2c-d2d0-b003-d9143fcca1c5	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
63629-3868-1	Ciprofloxacin	20 in 1 BOTTLE	TABLET, FILM COATED	20	1008
63629-3868-2	Ciprofloxacin	28 in 1 BOTTLE	TABLET, FILM COATED	28	1008
63629-3868-3	Ciprofloxacin	14 in 1 BOTTLE	TABLET, FILM COATED	14	1008
63629-3868-4	Ciprofloxacin	30 in 1 BOTTLE	TABLET, FILM COATED	30	1008
63629-3868-5	Ciprofloxacin	60 in 1 BOTTLE	TABLET, FILM COATED	60	1008
63629-3868-6	Ciprofloxacin	10 in 1 BOTTLE	TABLET, FILM COATED	10	1008
63629-3868-7	Ciprofloxacin	90 in 1 BOTTLE	TABLET, FILM COATED	90	1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-3868-1	EA - Each	63629-3868	b636fbbf-4add-45df-8eba-08fd8dda3fec	1	2012-07-24
63629-3868-2	EA - Each	63629-3868	9b1e94ca-a31d-49ce-94e8-06432beb9d99	1	2012-07-24
63629-3868-3	EA - Each	63629-3868	daa8327c-67d6-4a30-88db-1ca718711311	1	2012-07-24
63629-3868-4	EA - Each	63629-3868	08b487ab-acca-41c8-9a11-66b31121d6c7	1	2015-02-02
63629-3868-5	EA - Each	63629-3868	c844ba87-ec9d-4e07-b7ba-0e0d422f93a6	1	2015-02-02
63629-3868-6	EA - Each	63629-3868	3824f8a8-bae6-42fe-b51d-0c046d74d214	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CIPROFLOXACIN	ACTIVE INGREDIENT	5E8K9I0O4U	CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
CIPROFLOXACIN	ACTIVE MOIETY	5E8K9I0O4U	CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-3868	CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1008	Current NDC, Legacy NDC, 7 package rows	20240511_a57066d7-dc2c-d2d0-b003-d9143fcca1c5.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ciprofloxacin	CIPROFLOXACIN	REMEDYREPACK INC.	c08b37c3-5f01-47ed-9508-02813bbd008b	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076558 application number: ANDA076558
Ciprofloxacin	CIPROFLOXACIN	REMEDYREPACK INC.	44b6cefc-7638-4437-95e7-8f239f66a9d4	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076558 application number: ANDA076558
Ciprofloxacin	CIPROFLOXACIN	PD-Rx Pharmaceuticals, Inc.	3b9b15f7-354b-4049-982b-f6f31751a885	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076558 application number: ANDA076558
Ciprofloxacin	CIPROFLOXACIN	Northwind Health Company, LLC	f67d727f-b9ca-aec0-e053-2995a90aab69	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076558 application number: ANDA076558
Ciprofloxacin	CIPROFLOXACIN	PD-Rx Pharmaceuticals, Inc.	fa32aafd-e3f5-4be6-9413-c7663c1c2cec	2025-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076558 application number: ANDA076558
Ciprofloxacin	CIPROFLOXACIN	PD-Rx Pharmaceuticals, Inc.	5723eaf9-8659-4730-b792-4e4c33690ccb	2025-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076558 application number: ANDA076558
Ciprofloxacin	CIPROFLOXACIN	PD-Rx Pharmaceuticals, Inc.	d275175c-691a-4d09-bbb7-50ee819e6727	2025-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076558 application number: ANDA076558
CIPROFLOXACIN	CIPROFLOXACIN	DirectRx	d23e359d-6d12-38f6-e053-2a95a90a0a88	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076558 application number: ANDA076558
Ciprofloxacin	CIPROFLOXACIN	DirectRx	d358eb18-f4d0-e9ba-e053-2a95a90a435d	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076558 application number: ANDA076558
Ciprofloxacin	CIPROFLOXACIN	Golden State Medical Supply, Inc.	2e1addcf-6d5b-46c8-812b-558fd847f005	2025-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076558 application number: ANDA076558
Ciprofloxacin	CIPROFLOXACIN	Hikma Pharmaceuticals USA Inc.	3b3d22dc-df09-4910-8c9b-1204eeedbd68	2024-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076558 application number: ANDA076558
Ciprofloxacin	CIPROFLOXACIN	Bryant Ranch Prepack	4f600112-168a-4a58-9914-7c01f71894da	2024-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076558 application number: ANDA076558
Ciprofloxacin	CIPROFLOXACIN	Bryant Ranch Prepack	a57066d7-dc2c-d2d0-b003-d9143fcca1c5	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076558 application number: ANDA076558 ndc (product): 63629-3868
Ciprofloxacin	CIPROFLOXACIN	Asclemed USA, Inc.	1bb1d26e-fad0-4338-8948-3f095d5817a6	2022-03-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076558 application number: ANDA076558

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
197512	ciprofloxacin 750 MG Oral Tablet	PSN	a57066d7-dc2c-d2d0-b003-d9143fcca1c5	1008
197512	ciprofloxacin 750 MG Oral Tablet	SCD	a57066d7-dc2c-d2d0-b003-d9143fcca1c5	1008
197512	ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral Tablet	SY	a57066d7-dc2c-d2d0-b003-d9143fcca1c5	1008

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-3868-1	63629386801	20 TABLET, FILM COATED in 1 BOTTLE (63629-3868-1)	2008-10-30	0000-00-00	No	No	Current
63629-3868-2	63629386802	28 TABLET, FILM COATED in 1 BOTTLE (63629-3868-2)	2009-06-12	0000-00-00	No	No	Current
63629-3868-3	63629386803	14 TABLET, FILM COATED in 1 BOTTLE (63629-3868-3)	2013-04-23	0000-00-00	No	No	Current
63629-3868-4	63629386804	30 TABLET, FILM COATED in 1 BOTTLE (63629-3868-4)	2011-07-26	0000-00-00	No	No	Current
63629-3868-5	63629386805	60 TABLET, FILM COATED in 1 BOTTLE (63629-3868-5)	2010-12-14	0000-00-00	No	No	Current
63629-3868-6	63629386806	10 TABLET, FILM COATED in 1 BOTTLE (63629-3868-6)	2013-12-03	0000-00-00	No	No	Current
63629-3868-7	63629386807	90 TABLET, FILM COATED in 1 BOTTLE (63629-3868-7)	2023-03-06	0000-00-00	No	No	Current