Ciprofloxacin

Product NDC: 43063-547
11-digit product format: 430630547
Labeler code: 43063
Product ID: 43063-547_42ef2624-a5bf-f4f7-e063-6294a90a1400
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ciprofloxacin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 126 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	A076126-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076126-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076126-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A076126-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076126-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076126-004	AB	1	`caaa826d4ba7…`
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…`

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
74e2dd24-5c6e-4dde-a2ab-f2d2e61734d8	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
43063-547-01	Ciprofloxacin	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	31
43063-547-20	Ciprofloxacin	20 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	20	31
43063-547-82	Ciprofloxacin	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500	31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-547-01	EA - Each	43063-547	2e90d21c-03ad-4584-94b9-02174db336a2	1	2019-02-13
43063-547-02	EA - Each	43063-547	87af93ea-d3ee-4abb-b919-a2cf0ae5305c	1	2015-08-04
43063-547-03	EA - Each	43063-547	c3024e42-e58b-4db5-b72a-2367bf48e999	1	2016-03-04
43063-547-04	EA - Each	43063-547	347ceb6f-804e-493b-8ea3-c4f14a7549e5	1	2016-03-04
43063-547-06	EA - Each	43063-547	f24ffd5d-c95c-406e-8754-b8cce0c80dec	1	2015-09-10
43063-547-10	EA - Each	43063-547	da48accc-0f67-44b5-ac76-a843dc98ac82	1	2015-01-05
43063-547-14	EA - Each	43063-547	f560f7c5-f008-4478-b484-4d1daacd8930	1	2015-11-12
43063-547-20	EA - Each	43063-547	ddf5dba9-0bb5-4d1f-8c78-7fdacbdb8124	1	2015-01-05
43063-547-28	EA - Each	43063-547	75db15ad-23e3-42a6-8e0f-35cb89447872	1	2019-01-24
43063-547-30	EA - Each	43063-547	2138bd30-9468-4078-91fa-053ddbea2b0c	1	2015-01-05
43063-547-79	EA - Each	43063-547	974a3b0d-12d0-4382-8e70-7cc4b9764b5f	1	2015-11-12
43063-547-82	EA - Each	43063-547	6fa24984-c73d-4e63-859c-de53fc06ac3e	1	2020-06-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CIPROFLOXACIN HYDROCHLORIDE	ACTIVE INGREDIENT	4BA73M5E37	CIPROFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	11
CIPROFLOXACIN	ACTIVE MOIETY	5E8K9I0O4U	CIPROFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	11
HYPROMELLOSE 2208 (15000 MPA.S)	INACTIVE INGREDIENT	Z78RG6M2N2	CIPROFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	11
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CIPROFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CIPROFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	11
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)	INACTIVE INGREDIENT	461P5CJN6T	CIPROFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	11
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CIPROFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CIPROFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	11
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	CIPROFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-547	CIPROFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	30	Current NDC, Legacy NDC, 3 package rows	20250305_74e2dd24-5c6e-4dde-a2ab-f2d2e61734d8.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 ndc (product): 43063-547
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
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
5E8K9I0O4U	CIPROFLOXACIN	85721-33-1	Ciprofloxacin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309309	ciprofloxacin 500 MG Oral Tablet	PSN	74e2dd24-5c6e-4dde-a2ab-f2d2e61734d8	31
309309	ciprofloxacin 500 MG Oral Tablet	SCD	74e2dd24-5c6e-4dde-a2ab-f2d2e61734d8	31
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	74e2dd24-5c6e-4dde-a2ab-f2d2e61734d8	31
309309	ciprofloxacin 500 MG Oral Tablet	PSN	c7bc0d20-526c-48ea-b23a-cea9eb7080ff	1
309309	ciprofloxacin 500 MG Oral Tablet	SCD	c7bc0d20-526c-48ea-b23a-cea9eb7080ff	1
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	c7bc0d20-526c-48ea-b23a-cea9eb7080ff	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-547-01	43063054701	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-01)	2019-01-07	0000-00-00	No	No	Current
43063-547-02	43063054702	2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-02)	2015-07-06	0000-00-00	No	No	Current
43063-547-03	43063054703	3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-03)	2016-01-29	0000-00-00	No	No	Current
43063-547-04	43063054704	4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-04)	2015-11-17	0000-00-00	No	No	Current
43063-547-06	43063054706	6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-06)	2015-12-07	0000-00-00	No	No	Current
43063-547-10	43063054710	10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-10)	2014-11-05	0000-00-00	No	No	Current
43063-547-14	43063054714	14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-14)	2015-09-08	0000-00-00	No	No	Current
43063-547-20	43063054720	20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-20)	2014-11-05	0000-00-00	No	No	Current
43063-547-28	43063054728	28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-28)	2017-01-12	0000-00-00	No	No	Current
43063-547-30	43063054730	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-30)	2014-11-05	0000-00-00	No	No	Current
43063-547-79	43063054779	1 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-79)	2015-08-31	0000-00-00	No	No	Current
43063-547-82	43063054782	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-82)	2020-05-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ciprofloxacin	PD-Rx Pharmaceuticals, Inc.	2025-11-06	HUMAN PRESCRIPTION DRUG LABEL	31
Ciprofloxacin	Aphena Pharma Solutions - Tennessee, LLC	2018-07-09	HUMAN PRESCRIPTION DRUG LABEL	1