CETRAXAL

Product NDC: 66992-450
11-digit product format: 669920450
Labeler code: 66992
Product ID: 66992-450_ca024935-ff23-4a29-8d2a-8337938d5808
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ciprofloxacin
Dosage form: SOLUTION/ DROPS
Route: AURICULAR (OTIC)
Labeler: Wraser Llc
Application: NDA021918
Marketing category: NDA
Marketing start: 2009-05-14
Marketing end: 0000-00-00
Substance: CIPROFLOXACIN HYDROCHLORIDE
Active strength: 1 mg/.25mL
Pharmacologic classes: Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	66992-450		I	Inactivated by FDA		2026-08-03
excluded package	package	66992-450	66992-450-14	I	Inactivated by FDA		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N021918-001	CETRAXAL	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OTIC	AB	RLD, RS	2009-05-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021918-001	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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC	AB	RLD, RS	2009-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC	AB	RLD, RS	2009-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC	AB	RLD, RS	2009-05-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC	AB	RLD, RS	2009-05-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC	AB	RLD, RS	2009-05-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC	AB	RLD, RS	2009-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC	AB	RLD, RS	2009-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC	AB	RLD, RS	2009-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021918-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021918-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021918-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021918-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021918-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021918-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021918-001	AB	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021918-001	AB	1	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021918-001	AB	1	`a50c72e98297…`

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66992-450-14	2024-04-21	C162847	48780-1	ba0f9c33-3969-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use Cetraxal safely and effectively. See full prescribing information for Cetraxal. Cetraxal (Ciprofloxacin otic solution) 0.2% Initial U.S. Approval: 1987
66992-450-14	2024-01-30	C162847	48780-1	ba0f9c33-3969-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use Cetraxal safely and effectively. See full prescribing information for Cetraxal. Cetraxal (Ciprofloxacin otic solution) 0.2% Initial U.S. Approval: 1987
66992-450-14	2021-02-02	C162847	48780-1	ba0f9c33-3969-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use Cetraxal safely and effectively. See full prescribing information for Cetraxal. Cetraxal (Ciprofloxacin otic solution) 0.2% Initial U.S. Approval: 1987
66992-450-14	2021-01-29	C162847	48780-1	ba0f9c33-3969-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use Cetraxal safely and effectively. See full prescribing information for Cetraxal. Cetraxal (Ciprofloxacin otic solution) 0.2% Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66992-450-14	CETRAXAL	14 in 1 CARTON	SOLUTION/ DROPS	14		8
66992-450-14	CETRAXAL	0.25 mL in 1 CONTAINER	SOLUTION/ DROPS	0.25		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66992-450-14	EA - Each	66992-450	7e048e6b-5251-4106-aa7d-a2e0b884c75e	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Ciprofloxacin	ACTIVE INGREDIENT	5E8K9I0O4U	CETRAXAL (CIPROFLOXACIN) SOLUTION/ DROPS [WRASER PHARMACEUTICALS]	1
Ciprofloxacin	ACTIVE MOIETY	5E8K9I0O4U	CETRAXAL (CIPROFLOXACIN) SOLUTION/ DROPS [WRASER PHARMACEUTICALS]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	CETRAXAL (CIPROFLOXACIN) SOLUTION/ DROPS [WRASER PHARMACEUTICALS]	1
lactic acid	INACTIVE INGREDIENT	33X04XA5AT	CETRAXAL (CIPROFLOXACIN) SOLUTION/ DROPS [WRASER PHARMACEUTICALS]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	CETRAXAL (CIPROFLOXACIN) SOLUTION/ DROPS [WRASER PHARMACEUTICALS]	1
Sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	CETRAXAL (CIPROFLOXACIN) SOLUTION/ DROPS [WRASER PHARMACEUTICALS]	1
water	INACTIVE INGREDIENT	059QF0KO0R	CETRAXAL (CIPROFLOXACIN) SOLUTION/ DROPS [WRASER PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66992-450	CETRAXAL (CIPROFLOXACIN) SOLUTION/ DROPS [WRASER LLC]	8	Legacy NDC, 2 package rows	20241011_213b339a-75e0-4b1d-9052-8ee82a65d713.zip

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
848960	Cetraxal 0.2 % Otic Solution	PSN	213b339a-75e0-4b1d-9052-8ee82a65d713	8
848956	ciprofloxacin HCl 0.2 % Otic Solution	PSN	213b339a-75e0-4b1d-9052-8ee82a65d713	8
848960	ciprofloxacin 2 MG/ML Otic Solution [Cetraxal]	SBD	213b339a-75e0-4b1d-9052-8ee82a65d713	8
848956	ciprofloxacin 2 MG/ML Otic Solution	SCD	213b339a-75e0-4b1d-9052-8ee82a65d713	8
848960	Cetraxal 0.2 % (as ciprofloxacin HCl) Otic Solution	SY	213b339a-75e0-4b1d-9052-8ee82a65d713	8
848960	Cetraxal 0.2 % Otic Solution	SY	213b339a-75e0-4b1d-9052-8ee82a65d713	8
848960	Cetraxal 2 MG/ML Otic Solution	SY	213b339a-75e0-4b1d-9052-8ee82a65d713	8
848956	ciprofloxacin 0.2 % Otic Solution	SY	213b339a-75e0-4b1d-9052-8ee82a65d713	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66992-450-14	66992045014	14 CONTAINER in 1 CARTON (66992-450-14) > .25 mL in 1 CONTAINER	14 container	2009-05-14	0000-00-00	No	No	Current