Ciprofloxacin Hydrochloride

Product NDC: 76420-942
Requested package NDC: 76420-942-10
11-digit product format: 764200942
Labeler code: 76420
Product ID: 76420-942_3175dedd-a620-17ae-e063-6294a90aa1e8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ciprofloxacin Hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Asclemed USA, Inc.
Application: NDA019992
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2004-05-07
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N019992-001	CILOXAN	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019992-001	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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N019992-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019992-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019992-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019992-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019992-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019992-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019992-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019992-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019992-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019992-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019992-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019992-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019992-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019992-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019992-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019992-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019992-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019992-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019992-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019992-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019992-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019992-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019992-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019992-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019992-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019992-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019992-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019992-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019992-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019992-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019992-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019992-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019992-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019992-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019992-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019992-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019992-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019992-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019992-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019992-001	AT	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Ciprofloxacin Hydrochloride
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
509b932e-9229-42c0-8a4c-f3257ffdca49	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
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
a3304bb6-ef4e-06df-d604-35f7e883ed6c	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	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
76420-942-03	Ciprofloxacin Hydrochloride	2.5 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	2.5	1
76420-942-03	Ciprofloxacin Hydrochloride	1 in 1 CARTON	SOLUTION/ DROPS	1	1
76420-942-05	Ciprofloxacin Hydrochloride	5 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	5	1
76420-942-05	Ciprofloxacin Hydrochloride	1 in 1 CARTON	SOLUTION/ DROPS	1	1
76420-942-10	Ciprofloxacin Hydrochloride	1 in 1 CARTON	SOLUTION/ DROPS	1	1
76420-942-10	Ciprofloxacin Hydrochloride	10 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	10	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-942	CIPROFLOXACIN HYDROCHLORIDE SOLUTION/ DROPS [ASCLEMED USA, INC.]	1	Current NDC, 6 package rows	20250402_509b932e-9229-42c0-8a4c-f3257ffdca49.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 Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	Redpharm Drug	1ac4540c-d0f7-70bc-e063-6394a90a0f7a	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019992 application number: NDA019992
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	78641acd-eedf-4b68-bb18-da0874415f59	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019992 application number: NDA019992
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	REMEDYREPACK INC.	a2cec2cc-729b-4baa-8df1-c3f70847a483	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019992 application number: NDA019992
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	Asclemed USA, Inc.	509b932e-9229-42c0-8a4c-f3257ffdca49	2025-03-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019992 application number: NDA019992 ndc (package): 76420-942-10 ndc (product): 76420-942 ndc11 (package): 76420094210
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	5cf0f572-48fc-6a3a-e053-2991aa0a8437	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019992 application number: NDA019992
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	6301febb-01aa-1af5-e053-2991aa0aa309	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019992 application number: NDA019992
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	A-S Medication Solutions	ec3a3dcf-b9c9-432e-adfe-4b30cade8931	2024-11-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019992 application number: NDA019992
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	A-S Medication Solutions	694b79f6-599f-4a71-bf02-d0d09767a735	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019992 application number: NDA019992
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	54c73290-bd89-3453-e054-00144ff88e88	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019992 application number: NDA019992
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	Proficient Rx LP	e04dfddd-6177-4c2e-8f42-acd65848e6e2	2022-12-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019992 application number: NDA019992
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	Sandoz Inc	ab52b14d-345b-47ff-a832-465caddd3801	2019-07-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019992 application number: NDA019992

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
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	509b932e-9229-42c0-8a4c-f3257ffdca49	1
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	509b932e-9229-42c0-8a4c-f3257ffdca49	1
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	509b932e-9229-42c0-8a4c-f3257ffdca49	1
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	509b932e-9229-42c0-8a4c-f3257ffdca49	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
76420-942-10	76420094210	1 BOTTLE, PLASTIC in 1 CARTON (76420-942-10) / 10 mL in 1 BOTTLE, PLASTIC	2025-03-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ciprofloxacin Ophthalmic Solution 0.3% Sterile	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-03-29	HUMAN PRESCRIPTION DRUG LABEL	1