Ciprofloxacin

Product NDC: 80425-0492
Requested package NDC: 80425-0492-2
11-digit product format: 804250492
Labeler code: 80425
Product ID: 80425-0492_2d325eb5-e49e-6529-e063-6294a90a5cc1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ciprofolxacin
Dosage form: TABLET
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA208921
Marketing category: ANDA
Marketing start: 2025-02-02
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 1.

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 · 82 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	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…`
2021-12-28 21:50 UTC	2021-12	A208921-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2018-06-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208921-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2018-06-22	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	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…`
2021-12-28 21:50 UTC	2021-12	A208921-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208921-002	AB	1	`782e0a99824c…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
2d324cb1-8567-55e5-e063-6294a90aa5d9	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
80425-0492-1	Ciprofloxacin	20 in 1 BOTTLE	TABLET	20		1
80425-0492-2	Ciprofloxacin	30 in 1 BOTTLE	TABLET	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0492-1	EA - Each	80425-0492	e3c5f436-0c73-4765-b670-547dff730b55	1	2025-03-04
80425-0492-2	EA - Each	80425-0492	091de400-409b-4d31-bfcc-6012eb699182	1	2025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0492	CIPROFLOXACIN (CIPROFOLXACIN) TABLET [ADVANCED RX OF TENNESSEE, LLC]	1	Current NDC, 2 package rows	20250204_2d324cb1-8567-55e5-e063-6294a90aa5d9.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	2d324cb1-8567-55e5-e063-6294a90aa5d9	1
309309	ciprofloxacin 500 MG Oral Tablet	SCD	2d324cb1-8567-55e5-e063-6294a90aa5d9	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
80425-0492-2	80425049202	30 TABLET in 1 BOTTLE (80425-0492-2)	30 tablet	2025-02-02	No	No	Current