Fluconazole

Product NDC: 61919-493
11-digit product format: 619190493
Labeler code: 61919
Product ID: 61919-493_0e88c9e2-8dbd-917c-e063-6294a90a6ec9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluconazole
Dosage form: TABLET
Route: ORAL
Labeler: Direct Rx
Application: ANDA208963
Marketing category: ANDA
Marketing start: 2019-04-08
Substance: FLUCONAZOLE
Active strength: 200 mg/1
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: 2026-12-31
Current FDA listing: Yes

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

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	TE codes	Approval date
A208963-001	FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2017-02-16
A208963-002	FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2017-02-16
A208963-003	FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-16
A208963-004	FLUCONAZOLE	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2017-02-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A208963-001	AB
A208963-002	AB
A208963-003	AB
A208963-004	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 5 · 164 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	A208963-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2017-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208963-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2017-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208963-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208963-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2017-02-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208963-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2017-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208963-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2017-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208963-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208963-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2017-02-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208963-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2017-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208963-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2017-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208963-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208963-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2017-02-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208963-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2017-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208963-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2017-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208963-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208963-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2017-02-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208963-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2017-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208963-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2017-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208963-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208963-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2017-02-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208963-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2017-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208963-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2017-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208963-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208963-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2017-02-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208963-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2017-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208963-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2017-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208963-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208963-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2017-02-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208963-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2017-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208963-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2017-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208963-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208963-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2017-02-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208963-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2017-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208963-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2017-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208963-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208963-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2017-02-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208963-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2017-02-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208963-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2017-02-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208963-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208963-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2017-02-16	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A208963-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208963-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208963-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208963-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208963-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208963-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208963-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208963-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208963-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208963-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208963-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208963-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208963-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208963-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208963-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208963-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208963-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208963-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208963-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208963-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208963-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208963-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208963-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208963-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208963-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208963-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208963-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208963-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208963-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208963-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208963-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208963-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208963-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208963-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208963-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208963-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208963-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208963-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208963-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208963-004	AB	1	`d06236e962d9…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUCONAZOLE	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8VZV102JFY	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197700	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
69f199fa-bb92-4837-8b12-427a1c71f622	Available on FDA.report

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
61919-493-03	Fluconazole	3 in 1 BOTTLE	TABLET	3		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-493-03	EA - Each	61919-493	e6a37814-2f77-4593-be9c-7b9995b589e9	1	2019-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUCONAZOLE	ACTIVE INGREDIENT	8VZV102JFY	DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]	1
FLUCONAZOLE	ACTIVE MOIETY	8VZV102JFY	DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-493	FLUCONAZOLE TABLET [DIRECT RX]	6	Current NDC, Legacy NDC, 1 package rows	20240110_69f199fa-bb92-4837-8b12-427a1c71f622.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fluconazole	FLUCONAZOLE	A-S Medication Solutions	7961c029-746c-48c3-888b-8f8344102873	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208963 application number: ANDA208963
fluconazole	FLUCONAZOLE	REMEDYREPACK INC.	b5cfe0a1-f55c-41b1-8ad6-d1d0134a4d1d	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208963 application number: ANDA208963
fluconazole	FLUCONAZOLE	Preferred Pharmaceuticals Inc.	16b6fba0-b96f-4252-a70d-31dc61400298	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208963 application number: ANDA208963
fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	67af604c-928f-468b-ba27-ad45e95d3e7e	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208963 application number: ANDA208963
fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	7259671f-a703-4a2a-81db-9a4839b34072	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208963 application number: ANDA208963
fluconazole	FLUCONAZOLE	Zydus Pharmaceuticals (USA) Inc.	d1364455-1537-46d4-b093-38cca3be778f	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208963 application number: ANDA208963
fluconazole	FLUCONAZOLE	A-S Medication Solutions	1a8bd42a-2bce-4b41-8678-67033e7707dd	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208963 application number: ANDA208963
FLUCONAZOLE	FLUCONAZOLE	direct rx	b3db505a-9677-6f5a-e053-2a95a90a13d4	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208963 application number: ANDA208963
fluconazole	FLUCONAZOLE	NuCare Pharmaceuticals,Inc.	715c53f0-2aea-1f24-e053-2995a90ad463	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208963 application number: ANDA208963
fluconazole	FLUCONAZOLE	Zydus Lifesciences Limited	0adb2f88-8a6f-4f33-9e2d-73f537e05313	2024-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208963 application number: ANDA208963
Fluconazole	FLUCONAZOLE	Direct Rx	69f199fa-bb92-4837-8b12-427a1c71f622	2024-01-09	Adverse reactions	Exact identifier application applno (ANDA): 208963 application number: ANDA208963 ndc (product): 61919-493
fluconazole	FLUCONAZOLE	A-S Medication Solutions	08a54805-4fdf-48fd-bc3e-e9fa38f3c691	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208963 application number: ANDA208963
fluconazole	FLUCONAZOLE	Proficient Rx LP	f232600e-70ce-4001-b9da-31442f0920b9	2020-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208963 application number: ANDA208963
fluconazole	FLUCONAZOLE	Proficient Rx LP	7c8bb5ff-37e7-4f5e-8ea7-12269b2c7fd3	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208963 application number: ANDA208963

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	69f199fa-bb92-4837-8b12-427a1c71f622	6
197700	fluconazole 200 MG Oral Tablet	SCD	69f199fa-bb92-4837-8b12-427a1c71f622	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-493-03	61919049303	3 TABLET in 1 BOTTLE (61919-493-03)	3 tablet	2019-04-08	0000-00-00	No	No	Current