Ciprofloxacin

Product NDC: 63629-1010
Requested package NDC: 63629-1010-1
11-digit product format: 636291010
Labeler code: 63629
Product ID: 63629-1010_fc632cb9-a546-07a9-e053-6394a90a63b9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ciprofloxacin Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA076126
Marketing category: ANDA
Marketing start: 2009-10-10
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-1010	63629-1010-1	I	Inactivated by FDA		excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`

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	TE codes	Approval date
A076126-002	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09
A076126-003	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09
A076126-004	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A076126-002	AB
A076126-003	AB
A076126-004	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 · 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	A076126-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076126-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076126-004	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	A076126-002	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	A076126-003	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	A076126-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076126-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076126-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076126-004	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	A076126-002	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	A076126-003	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	A076126-004	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	A076126-002	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	A076126-003	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	A076126-004	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	A076126-002	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	A076126-003	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	A076126-004	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	A076126-002	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	A076126-003	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	A076126-004	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	A076126-002	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	A076126-003	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	A076126-004	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	A076126-002	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	A076126-003	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	A076126-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076126-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076126-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076126-004	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	A076126-002	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	A076126-003	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	A076126-004	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	A076126-002	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	A076126-003	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	A076126-004	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	A076126-002	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	A076126-003	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	A076126-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076126-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A076126-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076126-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076126-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076126-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076126-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076126-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076126-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076126-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076126-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076126-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076126-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076126-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076126-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076126-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076126-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076126-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076126-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076126-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076126-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076126-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076126-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076126-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076126-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076126-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076126-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076126-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076126-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076126-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076126-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076126-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076126-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076126-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076126-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076126-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076126-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076126-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076126-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076126-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076126-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076126-002	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	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
8eef4f14-e7ef-41be-be57-7993b333e8a9	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-1010-1	2020-07-10	These highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
63629-1010-2	2020-07-10	These highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
63629-1010-3	2020-07-10	These highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
63629-1010-4	2020-07-10	These highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
63629-1010-5	2020-07-10	These highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
63629-1010-6	2020-07-10	These highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
63629-1010-7	2020-07-10	These highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
63629-1010-8	2020-07-10	These highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
63629-1010-1	2020-01-31	These highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
63629-1010-2	2020-01-31	These highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
63629-1010-3	2020-01-31	These highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
63629-1010-4	2020-01-31	These highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
63629-1010-5	2020-01-31	These highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
63629-1010-6	2020-01-31	These highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
63629-1010-7	2020-01-31	These highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
63629-1010-8	2020-01-31	These highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63629-1010-1	Ciprofloxacin	100 in 1 BOTTLE	TABLET, FILM COATED	100	8
63629-1010-2	Ciprofloxacin	20 in 1 BOTTLE	TABLET, FILM COATED	20	8
63629-1010-3	Ciprofloxacin	30 in 1 BOTTLE	TABLET, FILM COATED	30	8
63629-1010-4	Ciprofloxacin	14 in 1 BOTTLE	TABLET, FILM COATED	14	8
63629-1010-5	Ciprofloxacin	500 in 1 BOTTLE	TABLET, FILM COATED	500	8
63629-1010-6	Ciprofloxacin	60 in 1 BOTTLE	TABLET, FILM COATED	60	8
63629-1010-7	Ciprofloxacin	10 in 1 BOTTLE	TABLET, FILM COATED	10	8
63629-1010-8	Ciprofloxacin	120 in 1 BOTTLE	TABLET, FILM COATED	120	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-1010-1	EA - Each	63629-1010	2dfced3d-162a-42d4-ae18-f735486fcad1	1	2020-08-06
63629-1010-2	EA - Each	63629-1010	7d8b681a-aa8e-4635-9e11-c77029d5b885	1	2020-08-06
63629-1010-3	EA - Each	63629-1010	24fada3e-611b-406d-a668-98df34cdebe4	1	2020-08-06
63629-1010-4	EA - Each	63629-1010	c41e90e9-6141-43bf-8152-2b97fe7966bf	1	2020-08-06
63629-1010-5	EA - Each	63629-1010	1471e390-dc94-4563-abe3-6a40568fc04e	1	2020-08-06
63629-1010-6	EA - Each	63629-1010	f1ae8c3d-e992-470a-b3fb-f0eb1e7cdef7	1	2020-08-06
63629-1010-7	EA - Each	63629-1010	253b519d-a863-4058-bd98-7329c1a6f12b	1	2020-08-06
63629-1010-8	EA - Each	63629-1010	ada4105a-0169-4864-bbb6-80b2aca02cb2	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-1010	CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]	8	Current NDC, Legacy NDC, 8 package rows	20230525_8eef4f14-e7ef-41be-be57-7993b333e8a9.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ciprofloxacin	CIPROFLOXACIN	PD-Rx Pharmaceuticals, Inc.	74e2dd24-5c6e-4dde-a2ab-f2d2e61734d8	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076126 application number: ANDA076126
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	cfda82e4-8660-447e-a881-b87165a31e9a	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076126 application number: ANDA076126
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	A-S Medication Solutions	1dca6149-00ca-480e-a887-6861e40803b9	2025-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076126 application number: ANDA076126
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	A-S Medication Solutions	6e37322b-89d3-4b66-8e1b-c4ad79eed173	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076126 application number: ANDA076126
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	bb2edaca-6cf2-4100-83f5-8ce142f68e59	2025-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076126 application number: ANDA076126
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Bryant Ranch Prepack	d6bd5021-cf56-4c8a-b5a0-bbc8919740af	2025-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076126 application number: ANDA076126
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Bryant Ranch Prepack	99918613-7936-47dd-8565-9cd6c0cc22e3	2025-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076126 application number: ANDA076126
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Golden State Medical Supply, Inc.	d17b0e87-b555-4dfb-e053-2a95a90aa5ef	2025-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076126 application number: ANDA076126
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Golden State Medical Supply, Inc.	1b54c195-71ba-2523-e063-6294a90ada73	2025-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076126 application number: ANDA076126
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Carlsbad Technology, Inc.	37527eca-115e-4582-88cd-bba851ac6069	2025-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076126 application number: ANDA076126
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Bryant Ranch Prepack	b283d662-9be1-49c7-be03-cb21055314c1	2024-10-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076126 application number: ANDA076126
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Bryant Ranch Prepack	8eef4f14-e7ef-41be-be57-7993b333e8a9	2023-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076126 application number: ANDA076126 ndc (package): 63629-1010-1 ndc (product): 63629-1010 ndc11 (package): 63629101001
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	de0b9579-fb85-e1ce-e053-2a95a90aeecb	2023-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076126 application number: ANDA076126
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Proficient Rx LP	a093ca6e-9963-4eea-b60d-6e2f148192ec	2022-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076126 application number: ANDA076126
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	df24efa3-c9a0-4f40-92ce-cc71c708931b	2018-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076126 application number: ANDA076126
Ciprofloxacin	CIPROFLOXACIN	Aphena Pharma Solutions - Tennessee, LLC	c7bc0d20-526c-48ea-b23a-cea9eb7080ff	2018-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076126 application number: ANDA076126

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	8eef4f14-e7ef-41be-be57-7993b333e8a9	8
309309	ciprofloxacin 500 MG Oral Tablet	SCD	8eef4f14-e7ef-41be-be57-7993b333e8a9	8
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	8eef4f14-e7ef-41be-be57-7993b333e8a9	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-1010-1	63629101001	100 TABLET, FILM COATED in 1 BOTTLE (63629-1010-1)	2020-12-07	0000-00-00	No	No	Current