ciprofloxacin

Product NDC: 68071-4672
Requested package NDC: 68071-4672-3
11-digit product format: 680714672
Labeler code: 68071
Product ID: 68071-4672_1ab88258-a402-2353-e063-6394a90a5eca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ciprofloxacin
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA077568
Marketing category: ANDA
Marketing start: 2018-11-01
Substance: CIPROFLOXACIN HYDROCHLORIDE
Active strength: 3 mg/mL
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 · 3 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	Archive	Snapshot	Source SHA-256
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-4672	68071-4672-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-4672	68071-4672-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-4672	68071-4672-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077568-001	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT		2008-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077568-001	AT

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 2 · 42 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	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A077568-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077568-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077568-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077568-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077568-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077568-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077568-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077568-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077568-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077568-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077568-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077568-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077568-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077568-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077568-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077568-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077568-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077568-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077568-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077568-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077568-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077568-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077568-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077568-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077568-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077568-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077568-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077568-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077568-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077568-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077568-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077568-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077568-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077568-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077568-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077568-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077568-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077568-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077568-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077568-001	AT	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CIPROFLOXACIN HYDROCHLORIDE	3 mg/mL

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
309307	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
7d533171-0879-3854-e053-2a91aa0a3b46	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a21a21e5-f36d-4c1f-8918-def921b8f7e3	Product name	3	20250124
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
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
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
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508
de5ea793-ffd9-0308-b0ca-00d9967be4ee	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-06-12	Ciprofloxacin ophthalmic solution USP 0.3% as base Sterile
2023-01-30	Ciprofloxacin ophthalmic solution USP 0.3% as base Sterile
2021-02-17	Ciprofloxacin ophthalmic solution USP 0.3% as base Sterile
2021-01-29	Ciprofloxacin ophthalmic solution USP 0.3% as base Sterile

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-4672-3	ciprofloxacin	2.5 mL in 1 BOTTLE	SOLUTION	2.5		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-4672	CIPROFLOXACIN SOLUTION [NUCARE PHARMACEUTICALS,INC.]	4	Current NDC, Legacy NDC, 1 package rows	20240614_7d533171-0879-3854-e053-2a91aa0a3b46.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ciprofloxacin	CIPROFLOXACIN	HAWAII REPACK, INC	4caf49d9-b06f-4d57-aac3-cc64ae12cc95	2026-07-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077568 application number: ANDA077568
ciprofloxacin	CIPROFLOXACIN	Redpharm Drug	541bd97e-b2ff-09a8-e063-6394a90aee96	2026-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077568 application number: ANDA077568
ciprofloxacin	CIPROFLOXACIN	Sportpharm LLC	190395a8-c05f-4e31-9a89-7af6428ebbb9	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077568 application number: ANDA077568
ciprofloxacin	CIPROFLOXACIN	Preferred Pharmaceuticals, Inc.	85c48ebc-d94a-4254-86df-d2c1aff09b37	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077568 application number: ANDA077568
ciprofloxacin	CIPROFLOXACIN	Advanced Rx of Tennessee, LLC	30cb2b42-aa4b-8cec-e063-6394a90aa615	2025-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077568 application number: ANDA077568
ciprofloxacin	CIPROFLOXACIN	A-S Medication Solutions	766251ac-2040-4a79-9ca5-a1e5f1e01cb5	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077568 application number: ANDA077568
ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals,Inc.	7def5a45-6725-0521-e053-2991aa0a0bda	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077568 application number: ANDA077568
ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals,Inc.	7d533171-0879-3854-e053-2a91aa0a3b46	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077568 application number: ANDA077568 ndc (package): 68071-4672-3 ndc (product): 68071-4672 ndc11 (package): 68071467203
ciprofloxacin	CIPROFLOXACIN	Leading Pharma, LLC	545527e7-05c7-4dbf-ab32-b3fa463d55b0	2024-05-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077568 application number: ANDA077568
ciprofloxacin	CIPROFLOXACIN	Asclemed USA, Inc.	86c2ba30-9372-4e70-88a2-e6e1da07fa92	2023-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077568 application number: ANDA077568
ciprofloxacin	CIPROFLOXACIN	Proficient Rx LP	05b2836d-cd3d-4d7f-970c-66ec2d788667	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077568 application number: ANDA077568

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
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	7d533171-0879-3854-e053-2a91aa0a3b46	4
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	7d533171-0879-3854-e053-2a91aa0a3b46	4
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	7d533171-0879-3854-e053-2a91aa0a3b46	4
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	7d533171-0879-3854-e053-2a91aa0a3b46	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-4672-3	68071467203	2.5 mL in 1 BOTTLE (68071-4672-3)	2.5 ml	2018-12-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ciprofloxacin ophthalmic solution USP 0.3% as base Sterile	NuCare Pharmaceuticals,Inc.	2024-06-12	HUMAN PRESCRIPTION DRUG LABEL	4