OTOVEL

Product NDC: 66992-128
11-digit product format: 669920128
Labeler code: 66992
Product ID: 66992-128_1f604776-2e24-4326-8c16-9850737b105a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ciprofloxacin and fluocinolone acetonide
Dosage form: SOLUTION
Route: AURICULAR (OTIC)
Labeler: WraSer LLC
Application: NDA208251
Marketing category: NDA
Marketing start: 2021-10-04
Marketing end: 0000-00-00
Substance: CIPROFLOXACIN; FLUOCINOLONE ACETONIDE
Active strength: 1 mg/.25mL; mg/.25mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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	66992-128		I	Inactivated by FDA		2026-09-09
excluded package	package	66992-128	66992-128-14	I	Inactivated by FDA		2026-09-09

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 · 2 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
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	66992-128		I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	66992-128	66992-128-14	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
N208251-001	OTOVEL	CIPROFLOXACIN HYDROCHLORIDE; FLUOCINOLONE ACETONIDE	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC		RLD, RS	2016-04-29

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208251-001	OTOVEL	EQ 0.3% BASE;0.025%	SOLUTION/DROPS / OTIC	RLD, RS	2016-04-29	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208251-001	8932610	2030-03-24	U-1578	Drug product	2016-05-09	`e64feba35796…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N208251-001	NC	2019-04-29	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N208251-001	NC	2019-04-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208251-001	NC	2019-04-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208251-001	NC	2019-04-29	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0adb2af5-1ecf-4df5-912b-16ae89228294	Product name	6	20240829
ea50b939-d92a-4100-84f5-1c1089663837	Product name	2	20240705
65f6255d-41cc-425f-ba54-b1bea4947886	Product name	5	20210930
5ba208e4-886f-44da-e218-ab4f4cad2c49	Product name	5	20190612
e5a2793f-318b-72fd-b734-c44ecc6f6748	Product name	2	20190213
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
7df2570a-c555-4d82-9189-9247c722b62c	Product name	1	20150402
85490a6b-2306-6bf2-c51b-eb63537dc2da	Product name	1	20140508
a3304bb6-ef4e-06df-d604-35f7e883ed6c	Product name	1	20140508
a78a3633-fd06-b0af-63b3-c714de3b3bfa	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
b2d0a9c2-fd0c-a9b4-ae41-f6a4eef4fbf6	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
66992-128-14	2024-04-21	C162847	48780-1	1030e365-590d-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use OTOVEL safely and effectively. See full prescribing information for OTOVEL. OTOVEL (ciprofloxacin and fluocinolone acetonide) otic solution Initial U.S. Approval: 2016
66992-128-14	2024-01-30	C162847	48780-1	1030e365-590d-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use OTOVEL safely and effectively. See full prescribing information for OTOVEL. OTOVEL (ciprofloxacin and fluocinolone acetonide) otic solution Initial U.S. Approval: 2016

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66992-128-14	OTOVEL	14 in 1 POUCH	SOLUTION	14		5
66992-128-14	OTOVEL	1 in 1 CARTON	SOLUTION	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66992-128-14	EA - Each	66992-128	7b0b1fa9-610e-4eec-9432-4c4909955373	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66992-128	OTOVEL (CIPROFLOXACIN AND FLUOCINOLONE ACETONIDE) SOLUTION [WRASER LLC]	5	Legacy NDC, 2 package rows	20241011_dc17b816-b97f-4c44-9f05-b41f76ab3a52.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5E8K9I0O4U	CIPROFLOXACIN	85721-33-1	CIPROFLOXACIN
0CD5FD6S2M	FLUOCINOLONE ACETONIDE	67-73-2	FLUOCINOLONE ACETONIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1792386	ciprofloxacin 0.3 % / fluocinolone acetonide 0.025 % Otic Solution	PSN	dc17b816-b97f-4c44-9f05-b41f76ab3a52	5
1792391	Otovel 0.3 % / 0.025 % Otic Solution	PSN	dc17b816-b97f-4c44-9f05-b41f76ab3a52	5
1792391	ciprofloxacin 3 MG/ML / fluocinolone acetonide 0.25 MG/ML Otic Solution [Otovel]	SBD	dc17b816-b97f-4c44-9f05-b41f76ab3a52	5
1792386	ciprofloxacin 3 MG/ML / fluocinolone acetonide 0.25 MG/ML Otic Solution	SCD	dc17b816-b97f-4c44-9f05-b41f76ab3a52	5
1792386	ciprofloxacin 0.3 % / fluocinolone acetonide 0.025 % Otic Solution	SY	dc17b816-b97f-4c44-9f05-b41f76ab3a52	5
1792391	Otovel (ciprofloxacin 0.3 % / fluocinolone acetonide 0.025 % ) Otic Solution	SY	dc17b816-b97f-4c44-9f05-b41f76ab3a52	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66992-128-14	66992012814	1 POUCH in 1 CARTON (66992-128-14) > 14 VIAL, SINGLE-DOSE in 1 POUCH > .25 mL in 1 VIAL, SINGLE-DOSE	1 pouch	2021-10-04	0000-00-00	No	No	Current