Fluconazole

Product NDC: 33261-229
11-digit product format: 332610229
Labeler code: 33261
Product ID: 33261-229_47349194-fbe8-4176-86f2-67454764c301
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluconazole
Dosage form: TABLET
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA076077
Marketing category: ANDA
Marketing start: 2004-07-29
Marketing end: 0000-00-00
Substance: FLUCONAZOLE
Active strength: 200 mg/1
Pharmacologic classes: Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	33261-229		I	Inactivated by FDA	2026-09-14
excluded package	package	33261-229	33261-229-06	I	Inactivated by FDA	2026-09-14
excluded package	package	33261-229	33261-229-07	I	Inactivated by FDA	2026-09-14
excluded package	package	33261-229	33261-229-31	I	Inactivated by FDA	2026-09-14
excluded package	package	33261-229	33261-229-40	I	Inactivated by FDA	2026-09-14

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 2 · 105 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	33261-229-31	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-229-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-229-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-229-07	`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	33261-229-31	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-229-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-229-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-229-07	`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	33261-229-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-229-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-229-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-229-07	`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	33261-229-31	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-229-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-229-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-229-07	`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	33261-229-31	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-229-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-229-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-229-07	`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	33261-229-31	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-229-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-229-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-229-07	`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	33261-229-31	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-229-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-229-40	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-229-07	`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	33261-229-31	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-229-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-229-40	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-229-07	`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	33261-229-31	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-229-06	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-229-40	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-229-07	`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	33261-229-31	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-229-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-229-40	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-229-07	`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	33261-229-31	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	33261-229-06	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	33261-229-40	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	33261-229-07	`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	33261-229-31	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	33261-229-06	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	33261-229-40	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	33261-229-07	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A076077-001	FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29
A076077-002	FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29
A076077-003	FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29
A076077-004	FLUCONAZOLE	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076077-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076077-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076077-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076077-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076077-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076077-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076077-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076077-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076077-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076077-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076077-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076077-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076077-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076077-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076077-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076077-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076077-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076077-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076077-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076077-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076077-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076077-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076077-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076077-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076077-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076077-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076077-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076077-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076077-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076077-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076077-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076077-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076077-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076077-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076077-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076077-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076077-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076077-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076077-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076077-004	AB	1	`c0c555d07b60…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
74f0b828-cb79-42cb-bb6c-81c9f5bd2648	Product name	2	20250623
fe6bb120-ebc6-6290-9eab-e842fdb6c841	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
33261-229-06	FLUCONAZOLE TABLETS
33261-229-07	FLUCONAZOLE TABLETS
33261-229-31	FLUCONAZOLE TABLETS
33261-229-40	FLUCONAZOLE TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
33261-229-06	Fluconazole	6 in 1 BOTTLE, PLASTIC	TABLET	6	1
33261-229-07	Fluconazole	7 in 1 BOTTLE, PLASTIC	TABLET	7	1
33261-229-31	Fluconazole	3 in 1 BOTTLE, PLASTIC	TABLET	3	1
33261-229-40	Fluconazole	40 in 1 BOTTLE, PLASTIC	TABLET	40	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33261-229-06	EA - Each	33261-229	65367f8f-62b5-4df2-97b0-fae93cd9294c	1	2015-10-02
33261-229-07	EA - Each	33261-229	4ea21e8d-5a67-49c4-8f42-294dbabdeb4f	1	2015-10-02
33261-229-31	EA - Each	33261-229	6f1bea24-4b90-4791-918e-42c0eb6126d4	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUCONAZOLE	ACTIVE INGREDIENT	8VZV102JFY	FLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
FLUCONAZOLE	ACTIVE MOIETY	8VZV102JFY	FLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	FLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	FLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33261-229	FLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 4 package rows	20140107_f5f31f75-2be5-4c12-a8f0-1f1f5ac05a3e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8VZV102JFY	FLUCONAZOLE	86386-73-4	FLUCONAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197700	fluconazole 200 MG Oral Tablet	PSN	f5f31f75-2be5-4c12-a8f0-1f1f5ac05a3e	1
197700	fluconazole 200 MG Oral Tablet	SCD	f5f31f75-2be5-4c12-a8f0-1f1f5ac05a3e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
33261-229-06	33261022906	6 in 1 BOTTLE, PLASTIC	Historical
33261-229-07	33261022907	7 in 1 BOTTLE, PLASTIC	Historical
33261-229-31	33261022931	3 in 1 BOTTLE, PLASTIC	Historical
33261-229-40	33261022940	40 in 1 BOTTLE, PLASTIC	Historical