Ciprofloxacin

Product NDC: 43547-689
11-digit product format: 435470689
Labeler code: 43547
Product ID: 43547-689_d02ca299-0a85-451c-990e-eb006905fd0a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ciprofolxacin
Dosage form: TABLET
Route: ORAL
Labeler: Solco Healthcare US, LLC
Application: ANDA208921
Marketing category: ANDA
Marketing start: 2023-10-01
Substance: CIPROFLOXACIN HYDROCHLORIDE
Active strength: 500 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 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208921-001	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB		2018-06-22
A208921-002	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB		2018-06-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A208921-001	AB
A208921-002	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 3 · 84 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
2026-08-18 06:07:40	2026-07	A208921-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2018-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208921-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2018-06-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208921-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2018-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208921-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2018-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208921-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2018-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208921-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2018-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208921-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2018-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208921-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2018-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208921-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2018-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208921-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2018-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208921-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2018-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208921-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2018-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208921-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2018-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208921-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2018-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208921-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2018-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208921-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2018-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208921-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2018-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208921-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2018-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208921-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2018-06-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208921-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2018-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208921-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2018-06-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208921-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2018-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208921-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2018-06-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208921-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2018-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208921-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2018-06-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208921-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2018-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208921-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2018-06-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208921-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2018-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208921-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2018-06-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208921-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2018-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208921-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2018-06-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208921-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2018-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208921-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2018-06-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208921-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2018-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208921-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2018-06-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208921-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2018-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208921-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2018-06-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208921-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2018-06-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208921-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2018-06-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208921-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2018-06-22	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A208921-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208921-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208921-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208921-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208921-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208921-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208921-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208921-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208921-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208921-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208921-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208921-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208921-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208921-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208921-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208921-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208921-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208921-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208921-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208921-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208921-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208921-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208921-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208921-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208921-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208921-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208921-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208921-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208921-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208921-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208921-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208921-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208921-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208921-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208921-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208921-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208921-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208921-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208921-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208921-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

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

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197511	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
b6dcfcef-d4ec-4463-a6b5-192cd8c7c0c3	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
43547-689-10	Ciprofloxacin	100 in 1 BOTTLE	TABLET	100		3
43547-689-50	Ciprofloxacin	500 in 1 BOTTLE	TABLET	500		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43547-689-10	EA - Each	43547-689	189a582f-00ca-4edc-a46d-ce8d01ee4b4d	1	2024-01-04
43547-689-50	EA - Each	43547-689	79abba36-a203-4afd-aae6-a69497c7d185	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43547-689	CIPROFLOXACIN (CIPROFOLXACIN) TABLET [SOLCO HEALTHCARE US, LLC]	1	Current NDC, 2 package rows	20231013_b6dcfcef-d4ec-4463-a6b5-192cd8c7c0c3.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 3 · 44 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ciprofloxacin	CIPROFOLXACIN	REMEDYREPACK INC.	c527d138-e32c-418f-9573-a3d8a796279f	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFLOXACIN	St. Mary's Medical Park Pharmacy	348e810c-e572-f3d2-e063-6394a90a0855	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFOLXACIN	Asclemed USA, Inc.	c4eecdf8-9e50-4e44-aca1-b9c19317d52a	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFLOXACIN	St. Mary's Medical Park Pharmacy	c32ccb5f-b9d7-0aff-e053-2995a90afe6d	2026-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFOLXACIN	ST. MARY'S MEDICAL PARK PHARMACY	24c43000-7620-3869-e063-6394a90a9631	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFLOXACIN	Bryant Ranch Prepack	5af16acc-51ce-41ed-b1c4-6b3fb38ef515	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFLOXACIN	Bryant Ranch Prepack	a05035e1-f941-4f7c-9321-91dd50ab149b	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFOLXACIN	Sportpharm LLC	d38b5160-4c1c-41d9-8f13-f9f877778f9c	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFOLXACIN	REMEDYREPACK INC.	4edc4fda-7834-46cc-a0ed-22f117e6e10b	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFOLXACIN	Proficient Rx LP	9f00ae9d-8707-4275-9eba-2ed72db8aea1	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFOLXACIN	Preferred Pharmaceuticals Inc.	4425d454-210d-4b9f-88ad-6b32a9e0d3bd	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFLOXACIN	Preferred Pharmaceuticals Inc.	18414c5a-8153-44f7-b27a-90c290af0a23	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals,Inc.	c2d8dcc9-23b0-75bb-e053-2995a90a02c8	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFLOXACIN	Direct_Rx	351b41db-622f-a1eb-e063-6294a90a5667	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals,Inc.	bf52e242-199b-4206-e053-2a95a90a1eb7	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals,Inc.	bf8d4359-a850-97b7-e053-2a95a90aa66a	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFLOXACIN	Northwind Health Company, LLC	f6debb60-d885-230b-e053-6394a90ad73a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFLOXACIN TABLETS	Yiling Pharmaceutical, Inc.	6fd3da0b-7428-ac8f-e053-2a91aa0aed9f	2025-12-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFOLXACIN	Redpharm Drug	3253a41f-4f0a-5d83-e063-6294a90a890c	2025-12-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921
Ciprofloxacin	CIPROFOLXACIN	NuCare Pharmaceutical, Inc.	24760182-4be8-9f43-e063-6294a90a269e	2025-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208921 application number: ANDA208921

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	ab16bacd-f73f-462e-82b2-b0abb1c49cec	100
309309	ciprofloxacin 500 MG Oral Tablet	SCD	ab16bacd-f73f-462e-82b2-b0abb1c49cec	100
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	ab16bacd-f73f-462e-82b2-b0abb1c49cec	100
309309	ciprofloxacin 500 MG Oral Tablet	PSN	c527d138-e32c-418f-9573-a3d8a796279f	10
309309	ciprofloxacin 500 MG Oral Tablet	SCD	c527d138-e32c-418f-9573-a3d8a796279f	10
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	c527d138-e32c-418f-9573-a3d8a796279f	10
309309	ciprofloxacin 500 MG Oral Tablet	PSN	1b189dba-0493-c9b4-e063-6294a90a7d1e	5
309309	ciprofloxacin 500 MG Oral Tablet	SCD	1b189dba-0493-c9b4-e063-6294a90a7d1e	5
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	1b189dba-0493-c9b4-e063-6294a90a7d1e	5
309309	ciprofloxacin 500 MG Oral Tablet	PSN	3253a41f-4f0a-5d83-e063-6294a90a890c	4
309309	ciprofloxacin 500 MG Oral Tablet	PSN	a0eda476-1625-4e9e-bb76-4f1cf05562f0	4
309309	ciprofloxacin 500 MG Oral Tablet	PSN	351b41db-622f-a1eb-e063-6294a90a5667	4
309309	ciprofloxacin 500 MG Oral Tablet	SCD	3253a41f-4f0a-5d83-e063-6294a90a890c	4
309309	ciprofloxacin 500 MG Oral Tablet	SCD	a0eda476-1625-4e9e-bb76-4f1cf05562f0	4
309309	ciprofloxacin 500 MG Oral Tablet	SCD	351b41db-622f-a1eb-e063-6294a90a5667	4
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	3253a41f-4f0a-5d83-e063-6294a90a890c	4
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	351b41db-622f-a1eb-e063-6294a90a5667	4
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	a0eda476-1625-4e9e-bb76-4f1cf05562f0	4
197511	ciprofloxacin 250 MG Oral Tablet	PSN	b6dcfcef-d4ec-4463-a6b5-192cd8c7c0c3	3
309309	ciprofloxacin 500 MG Oral Tablet	PSN	4425d454-210d-4b9f-88ad-6b32a9e0d3bd	3
309309	ciprofloxacin 500 MG Oral Tablet	PSN	b6dcfcef-d4ec-4463-a6b5-192cd8c7c0c3	3
309309	ciprofloxacin 500 MG Oral Tablet	PSN	24c43000-7620-3869-e063-6394a90a9631	3
197511	ciprofloxacin 250 MG Oral Tablet	SCD	b6dcfcef-d4ec-4463-a6b5-192cd8c7c0c3	3
309309	ciprofloxacin 500 MG Oral Tablet	SCD	4425d454-210d-4b9f-88ad-6b32a9e0d3bd	3
309309	ciprofloxacin 500 MG Oral Tablet	SCD	24c43000-7620-3869-e063-6394a90a9631	3
309309	ciprofloxacin 500 MG Oral Tablet	SCD	b6dcfcef-d4ec-4463-a6b5-192cd8c7c0c3	3
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	4425d454-210d-4b9f-88ad-6b32a9e0d3bd	3
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	24c43000-7620-3869-e063-6394a90a9631	3
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	b6dcfcef-d4ec-4463-a6b5-192cd8c7c0c3	3
197511	ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral Tablet	SY	b6dcfcef-d4ec-4463-a6b5-192cd8c7c0c3	3
197511	ciprofloxacin 250 MG Oral Tablet	PSN	d38b5160-4c1c-41d9-8f13-f9f877778f9c	2
197511	ciprofloxacin 250 MG Oral Tablet	PSN	c4eecdf8-9e50-4e44-aca1-b9c19317d52a	2
309309	ciprofloxacin 500 MG Oral Tablet	PSN	d38b5160-4c1c-41d9-8f13-f9f877778f9c	2
309309	ciprofloxacin 500 MG Oral Tablet	PSN	288ea7b2-ecf2-e8e0-e063-6294a90a306a	2
309309	ciprofloxacin 500 MG Oral Tablet	PSN	2b8288a2-18bf-423c-b175-33174be729d4	2
309309	ciprofloxacin 500 MG Oral Tablet	PSN	c4eecdf8-9e50-4e44-aca1-b9c19317d52a	2
309309	ciprofloxacin 500 MG Oral Tablet	PSN	0ce2221d-940f-4c07-ba2e-fccb491f6b9b	2
197511	ciprofloxacin 250 MG Oral Tablet	SCD	c4eecdf8-9e50-4e44-aca1-b9c19317d52a	2
197511	ciprofloxacin 250 MG Oral Tablet	SCD	d38b5160-4c1c-41d9-8f13-f9f877778f9c	2
309309	ciprofloxacin 500 MG Oral Tablet	SCD	0ce2221d-940f-4c07-ba2e-fccb491f6b9b	2
309309	ciprofloxacin 500 MG Oral Tablet	SCD	c4eecdf8-9e50-4e44-aca1-b9c19317d52a	2
309309	ciprofloxacin 500 MG Oral Tablet	SCD	d38b5160-4c1c-41d9-8f13-f9f877778f9c	2
309309	ciprofloxacin 500 MG Oral Tablet	SCD	2b8288a2-18bf-423c-b175-33174be729d4	2
309309	ciprofloxacin 500 MG Oral Tablet	SCD	288ea7b2-ecf2-e8e0-e063-6294a90a306a	2
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	c4eecdf8-9e50-4e44-aca1-b9c19317d52a	2
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	2b8288a2-18bf-423c-b175-33174be729d4	2
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	d38b5160-4c1c-41d9-8f13-f9f877778f9c	2
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	288ea7b2-ecf2-e8e0-e063-6294a90a306a	2
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	0ce2221d-940f-4c07-ba2e-fccb491f6b9b	2
197511	ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral Tablet	SY	c4eecdf8-9e50-4e44-aca1-b9c19317d52a	2
197511	ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral Tablet	SY	d38b5160-4c1c-41d9-8f13-f9f877778f9c	2
309309	ciprofloxacin 500 MG Oral Tablet	PSN	3134401f-72a3-6c37-e063-6294a90a8fa9	1
309309	ciprofloxacin 500 MG Oral Tablet	PSN	2d324cb1-8567-55e5-e063-6294a90aa5d9	1
309309	ciprofloxacin 500 MG Oral Tablet	SCD	3134401f-72a3-6c37-e063-6294a90a8fa9	1
309309	ciprofloxacin 500 MG Oral Tablet	SCD	2d324cb1-8567-55e5-e063-6294a90aa5d9	1
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	3134401f-72a3-6c37-e063-6294a90a8fa9	1
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	2d324cb1-8567-55e5-e063-6294a90aa5d9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
43547-689-10	43547068910	100 TABLET in 1 BOTTLE (43547-689-10)	100 tablet	2023-10-01	No	No	Current
43547-689-50	43547068950	500 TABLET in 1 BOTTLE (43547-689-50)	500 tablet	2023-10-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ciprofloxacin	REMEDYREPACK INC.	2026-07-29	HUMAN PRESCRIPTION DRUG LABEL	11
Ciprofloxacin	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2026-06-26	HUMAN PRESCRIPTION DRUG LABEL	3
Ciprofloxacin	ST. MARY'S MEDICAL PARK PHARMACY	2026-06-08	HUMAN PRESCRIPTION DRUG LABEL	4
Ciprofloxacin	Sportpharm LLC	2026-04-24	HUMAN PRESCRIPTION DRUG LABEL	2
Ciprofloxacin	Preferred Pharmaceuticals Inc.	2026-03-30	HUMAN PRESCRIPTION DRUG LABEL	3
Ciprofloxacin	Direct_Rx	2026-03-09	HUMAN PRESCRIPTION DRUG LABEL	4
Ciprofloxacin	Redpharm Drug	2025-12-24	HUMAN PRESCRIPTION DRUG LABEL	4
Ciprofloxacin	NuCare Pharmaceuticals,Inc.	2025-12-03	HUMAN PRESCRIPTION DRUG LABEL	5
Ciprofloxacin	NuCare Pharmaceutical, Inc.	2025-06-04	HUMAN PRESCRIPTION DRUG LABEL	2
Ciprofloxacin	Proficient Rx LP	2025-04-01	HUMAN PRESCRIPTION DRUG LABEL	2
Ciprofloxacin	Coupler LLC \| Yiling Pharmaceutical Ltd	2025-03-25	HUMAN PRESCRIPTION DRUG LABEL	1
Ciprofloxacin	Advanced Rx of Tennessee, LLC	2025-02-02	HUMAN PRESCRIPTION DRUG LABEL	1
Ciprofloxacin	Quality Care Products, LLC	2024-12-19	HUMAN PRESCRIPTION DRUG LABEL	4
Ciprofloxacin	Bryant Ranch Prepack	2024-11-12	HUMAN PRESCRIPTION DRUG LABEL	100
Ciprofloxacin	Solco Healthcare US, LLC \| Yiling Pharmaceutical Ltd	2024-10-31	HUMAN PRESCRIPTION DRUG LABEL	3
Ciprofloxacin	Bryant Ranch Prepack	2024-08-15	HUMAN PRESCRIPTION DRUG LABEL	2