fluocinolone acetonide

Product NDC: 68462-185
11-digit product format: 684620185
Labeler code: 68462
Product ID: 68462-185_cc1f615e-6cb2-4721-84c6-e5f170b64d90
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluocinolone acetonide
Dosage form: OIL
Route: AURICULAR (OTIC)
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA211815
Marketing category: ANDA
Marketing start: 2018-12-18
Substance: FLUOCINOLONE ACETONIDE
Active strength: .11 mg/mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68462-185		D	Discontinued by firm	2026-08-11
excluded package	package	68462-185	68462-185-01	D	Discontinued by firm	2026-08-11
excluded package	package	68462-185	68462-185-05	D	Discontinued by firm	2026-08-11
excluded package	package	68462-185	68462-185-11	D	Discontinued by firm	2026-08-11

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 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68462-185-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68462-185-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68462-185-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68462-185-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68462-185-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68462-185-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68462-185-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68462-185-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68462-185-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68462-185-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68462-185-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68462-185-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68462-185-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68462-185-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68462-185-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68462-185-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68462-185-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68462-185-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68462-185-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68462-185-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68462-185-11	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68462-185-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68462-185-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68462-185-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68462-185-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68462-185-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68462-185-11	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68462-185-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68462-185-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68462-185-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68462-185-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68462-185-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68462-185-11	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68462-185-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68462-185-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68462-185-11	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A211815-001	FLUOCINONIDE ACETONIDE	FLUOCINOLONE ACETONIDE	0.01%	OIL/DROPS / OTIC			2018-12-14

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC		2018-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC		2018-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211815-001	FLUOCINONIDE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	2018-12-14	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A211815-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211815-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211815-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211815-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211815-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211815-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211815-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211815-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211815-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211815-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211815-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211815-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211815-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211815-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211815-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211815-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211815-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211815-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211815-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211815-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211815-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211815-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211815-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211815-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211815-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211815-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211815-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211815-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211815-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211815-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211815-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211815-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211815-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211815-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211815-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211815-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211815-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211815-001	AT	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUOCINOLONE ACETONIDE	.11 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0CD5FD6S2M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1191299	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
a00224b0-3db5-4d40-b370-5ec5476e1e10	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0adb2af5-1ecf-4df5-912b-16ae89228294	Product name	6	20240829
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
9e453f34-aacb-44d5-a119-c0e3dc1fca2a	Product name	1	20160622
7df2570a-c555-4d82-9189-9247c722b62c	Product name	1	20150402
85490a6b-2306-6bf2-c51b-eb63537dc2da	Product name	1	20140508
a78a3633-fd06-b0af-63b3-c714de3b3bfa	Product name	1	20140508
b2d0a9c2-fd0c-a9b4-ae41-f6a4eef4fbf6	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68462-185-56	fluocinolone acetonide	1 in 1 CARTON	OIL	1		2
68462-185-56	fluocinolone acetonide	20 mL in 1 BOTTLE, DROPPER	OIL	20		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-185-56	ML - Milliliter	68462-185	23e77978-ec83-462c-946d-20a794c2aa31	1	2019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-185	FLUOCINOLONE ACETONIDE OIL [GLENMARK PHARMACEUTICALS INC., USA]	2	Current NDC, Legacy NDC, 2 package rows	20240104_a00224b0-3db5-4d40-b370-5ec5476e1e10.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fluocinolone acetonide	FLUOCINOLONE ACETONIDE	Glenmark Pharmaceuticals Inc., USA	a00224b0-3db5-4d40-b370-5ec5476e1e10	2018-12-18	Adverse reactions	Exact identifier application applno (ANDA): 211815 application number: ANDA211815 ndc (product): 68462-185

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0CD5FD6S2M	FLUOCINOLONE ACETONIDE	67-73-2	FLUOCINOLONE ACETONIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1191299	fluocinolone acetonide 0.01 % Oil for Otic Solution	PSN	a00224b0-3db5-4d40-b370-5ec5476e1e10	2
1191299	fluocinolone acetonide 0.1 MG/ML Otic Solution	SCD	a00224b0-3db5-4d40-b370-5ec5476e1e10	2
1191299	fluocinolone acetonide 0.01 % Auricular Oil	SY	a00224b0-3db5-4d40-b370-5ec5476e1e10	2
1191299	fluocinolone acetonide 0.01 % Oil for Otic Solution	SY	a00224b0-3db5-4d40-b370-5ec5476e1e10	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-185-56	68462018556	1 BOTTLE, DROPPER in 1 CARTON (68462-185-56) / 20 mL in 1 BOTTLE, DROPPER	2018-12-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluocinolone Acetonide Oil, 0.01% (Ear Drops) Rx only	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2018-12-18	HUMAN PRESCRIPTION DRUG LABEL	2