Diflucan

Product NDC: 0049-3440
11-digit product format: 000493440
Labeler code: 0049
Product ID: 0049-3440_796a849a-830f-4527-ab55-d48c0daa6241
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluconazole
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Roerig
Application: NDA020090
Marketing category: NDA
Marketing start: 1993-12-23
Marketing end: 0000-00-00
Substance: FLUCONAZOLE
Active strength: 350 mg/35mL
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0049-3440		D	Discontinued by firm	2026-08-10
excluded product	product	0049-3440		D	Discontinued by firm	2026-08-10
excluded package	package	0049-3440	0049-3440-19	D	Discontinued by firm	2026-08-10
excluded package	package	0049-3440	0049-3440-19	D	Discontinued by firm	2026-08-10

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 · 46 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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0049-3440-19	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0049-3440-19	`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 product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0049-3440-19	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0049-3440-19	`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 product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0049-3440-19	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0049-3440-19	`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 product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0049-3440-19	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0049-3440-19	`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 product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0049-3440-19	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0049-3440-19	`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 product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0049-3440-19	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0049-3440-19	`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 product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0049-3440-19	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0049-3440-19	`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 product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0049-3440-19	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0049-3440-19	`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 product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0049-3440-19	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0049-3440-19	`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 product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0049-3440-19	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0049-3440-19	`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 product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0049-3440-19	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0049-3440-19	`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	0049-3440-19	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020090-001	DIFLUCAN	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23
N020090-002	DIFLUCAN	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N020090-001	AB
N020090-002	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 3 · 82 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	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020090-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020090-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020090-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020090-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020090-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020090-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020090-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020090-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020090-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020090-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020090-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020090-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020090-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020090-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020090-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020090-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020090-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020090-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020090-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020090-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020090-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020090-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020090-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020090-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020090-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020090-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020090-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020090-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020090-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020090-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020090-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020090-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020090-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020090-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020090-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020090-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020090-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020090-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020090-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020090-002	AB	1	`782e0a99824c…`

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0049-3440-19	Diflucan	1 in 1 CARTON	POWDER, FOR SUSPENSION	1		57
0049-3440-19	Diflucan	35 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	35		57

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0049-3440-19	ML - Milliliter	0049-3440	6e9daf5f-96ac-4364-a479-5974113f05db	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUCONAZOLE	ACTIVE INGREDIENT	8VZV102JFY	DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]	22
FLUCONAZOLE	ACTIVE MOIETY	8VZV102JFY	DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]	22
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]	22
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]	22
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]	22
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]	22
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]	22
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]	22
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]	22
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]	22
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]	22
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]	22
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]	22
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]	22
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]	22
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]	22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0049-3440	DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]	54	Legacy NDC, 2 package rows	20250328_f694c617-3383-416c-91b6-b94fda371204.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluconazole	FLUCONAZOLE	Mylan Pharmaceuticals Inc.	737e0fac-a2d2-4053-a0d7-edbfb6248f69	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020090 application number: NDA020090
Diflucan	FLUCONAZOLE	Roerig	f694c617-3383-416c-91b6-b94fda371204	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020090 application number: NDA020090 ndc (product): 0049-3440

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
201900	Diflucan 10 MG in 1 mL Oral Suspension	PSN	f694c617-3383-416c-91b6-b94fda371204	57
207107	DIFLUCAN 100 MG Oral Tablet	PSN	f694c617-3383-416c-91b6-b94fda371204	57
207108	Diflucan 150 MG Oral Tablet	PSN	f694c617-3383-416c-91b6-b94fda371204	57
207112	Diflucan 200 MG Oral Tablet	PSN	f694c617-3383-416c-91b6-b94fda371204	57
201901	Diflucan 40 MG in 1 mL Oral Suspension	PSN	f694c617-3383-416c-91b6-b94fda371204	57
207106	DIFLUCAN 50 MG Oral Tablet	PSN	f694c617-3383-416c-91b6-b94fda371204	57
310352	fluconazole 10 MG in 1 mL Oral Suspension	PSN	f694c617-3383-416c-91b6-b94fda371204	57
197698	fluconazole 100 MG Oral Tablet	PSN	f694c617-3383-416c-91b6-b94fda371204	57
197699	fluconazole 150 MG Oral Tablet	PSN	f694c617-3383-416c-91b6-b94fda371204	57
197700	fluconazole 200 MG Oral Tablet	PSN	f694c617-3383-416c-91b6-b94fda371204	57
310353	fluconazole 40 MG in 1 mL Oral Suspension	PSN	f694c617-3383-416c-91b6-b94fda371204	57
197701	fluconazole 50 MG Oral Tablet	PSN	f694c617-3383-416c-91b6-b94fda371204	57
201900	fluconazole 10 MG/ML Oral Suspension [Diflucan]	SBD	f694c617-3383-416c-91b6-b94fda371204	57
207107	fluconazole 100 MG Oral Tablet [Diflucan]	SBD	f694c617-3383-416c-91b6-b94fda371204	57
207108	fluconazole 150 MG Oral Tablet [Diflucan]	SBD	f694c617-3383-416c-91b6-b94fda371204	57
207112	fluconazole 200 MG Oral Tablet [Diflucan]	SBD	f694c617-3383-416c-91b6-b94fda371204	57
201901	fluconazole 40 MG/ML Oral Suspension [Diflucan]	SBD	f694c617-3383-416c-91b6-b94fda371204	57
207106	fluconazole 50 MG Oral Tablet [Diflucan]	SBD	f694c617-3383-416c-91b6-b94fda371204	57
310352	fluconazole 10 MG/ML Oral Suspension	SCD	f694c617-3383-416c-91b6-b94fda371204	57
197698	fluconazole 100 MG Oral Tablet	SCD	f694c617-3383-416c-91b6-b94fda371204	57
197699	fluconazole 150 MG Oral Tablet	SCD	f694c617-3383-416c-91b6-b94fda371204	57
197700	fluconazole 200 MG Oral Tablet	SCD	f694c617-3383-416c-91b6-b94fda371204	57
310353	fluconazole 40 MG/ML Oral Suspension	SCD	f694c617-3383-416c-91b6-b94fda371204	57
197701	fluconazole 50 MG Oral Tablet	SCD	f694c617-3383-416c-91b6-b94fda371204	57
201900	Diflucan 10 MG per 1 ML Oral Suspension	SY	f694c617-3383-416c-91b6-b94fda371204	57
207107	Diflucan 100 MG Oral Tablet	SY	f694c617-3383-416c-91b6-b94fda371204	57
201901	Diflucan 1400 MG per 35 ML Oral Suspension	SY	f694c617-3383-416c-91b6-b94fda371204	57
207108	Diflucan 150 MG Oral Tablet	SY	f694c617-3383-416c-91b6-b94fda371204	57
207112	Diflucan 200 MG Oral Tablet	SY	f694c617-3383-416c-91b6-b94fda371204	57
201901	Diflucan 200 MG per 5 ML Oral Suspension	SY	f694c617-3383-416c-91b6-b94fda371204	57
201900	Diflucan 350 MG per 35 ML Oral Suspension	SY	f694c617-3383-416c-91b6-b94fda371204	57
201901	Diflucan 40 MG per 1 ML Oral Suspension	SY	f694c617-3383-416c-91b6-b94fda371204	57
207106	Diflucan 50 MG Oral Tablet	SY	f694c617-3383-416c-91b6-b94fda371204	57
201900	Diflucan 50 MG per 5 ML Oral Suspension	SY	f694c617-3383-416c-91b6-b94fda371204	57
310352	fluconazole 10 MG per 1 ML Oral Suspension	SY	f694c617-3383-416c-91b6-b94fda371204	57
310352	fluconazole 10 MG per ML Powder for Oral Suspension	SY	f694c617-3383-416c-91b6-b94fda371204	57
310353	fluconazole 1400 MG per 35 ML Oral Suspension	SY	f694c617-3383-416c-91b6-b94fda371204	57
310353	fluconazole 200 MG per 5 ML Oral Suspension	SY	f694c617-3383-416c-91b6-b94fda371204	57
310352	fluconazole 350 MG per 35 ML Powder for Oral Suspension	SY	f694c617-3383-416c-91b6-b94fda371204	57
310353	fluconazole 40 MG per 1 ML Oral Suspension	SY	f694c617-3383-416c-91b6-b94fda371204	57
310353	fluconazole 40 MG per ML Powder for Oral Suspension	SY	f694c617-3383-416c-91b6-b94fda371204	57
310352	fluconazole 50 MG per 5 ML Powder for Oral Suspension	SY	f694c617-3383-416c-91b6-b94fda371204	57

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0049-3440-19	00049344019	1 BOTTLE in 1 CARTON (0049-3440-19) > 35 mL in 1 BOTTLE	1 bottle	1993-12-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DIFLUCAN® (Fluconazole Tablets) (Fluconazole for Oral Suspension)	Roerig \| Pfizer Inc \| Pfizer Ireland Pharmaceuticals Unlimited Company \| Pfizer Manufacturing Deutschland GmbH	2026-04-02	HUMAN PRESCRIPTION DRUG LABEL	57
DIFLUCAN ® (Fluconazole in Dextrose Injection and Fluconazole in Sodium Chloride Injection, for intravenous use)	Roerig \| Pfizer Inc \| Pfizer Ireland Pharmaceuticals \| Pfizer Manufacturing Deutschland GmbH \| Pfizer Laboratories Div Pfizer Inc	2024-03-07	HUMAN PRESCRIPTION DRUG LABEL	48