Fluconazole

Product NDC: 16714-693
11-digit product format: 167140693
Labeler code: 16714
Product ID: 16714-693_06bbf63a-4457-4206-af05-246be0ddb301
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluconazole
Dosage form: TABLET
Route: ORAL
Labeler: NorthStar Rx LLC
Application: ANDA077731
Marketing category: ANDA
Marketing start: 2008-10-07
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
A077731-001	FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2008-10-07
A077731-002	FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2008-10-07
A077731-003	FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2008-10-07
A077731-004	FLUCONAZOLE	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2008-10-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077731-001	AB
A077731-002	AB
A077731-003	AB
A077731-004	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	A077731-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2008-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077731-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2008-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077731-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2008-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077731-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2008-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077731-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2008-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077731-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2008-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077731-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2008-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077731-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2008-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077731-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2008-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077731-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2008-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077731-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2008-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077731-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2008-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077731-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2008-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077731-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2008-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077731-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2008-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077731-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2008-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077731-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2008-10-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077731-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2008-10-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077731-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2008-10-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077731-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2008-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077731-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2008-10-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077731-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2008-10-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077731-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2008-10-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077731-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2008-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077731-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2008-10-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077731-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2008-10-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077731-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2008-10-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077731-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2008-10-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077731-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2008-10-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077731-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2008-10-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077731-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2008-10-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077731-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2008-10-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077731-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2008-10-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077731-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2008-10-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077731-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2008-10-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077731-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2008-10-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077731-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2008-10-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077731-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2008-10-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077731-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2008-10-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077731-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2008-10-07	`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	A077731-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077731-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077731-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077731-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077731-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077731-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077731-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077731-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077731-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077731-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077731-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077731-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077731-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077731-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077731-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077731-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077731-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077731-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077731-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077731-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077731-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077731-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077731-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077731-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077731-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077731-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077731-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077731-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077731-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077731-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077731-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077731-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077731-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077731-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077731-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077731-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077731-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077731-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077731-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077731-004	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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197698	Internal RxNorm lookup
197699	Internal RxNorm lookup
197700	Internal RxNorm lookup
197701	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
d2acccda-8068-46c1-8562-950d7f70ee06	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
16714-693-01	Fluconazole	30 in 1 BOTTLE	TABLET	30		19
16714-693-02	Fluconazole	100 in 1 BOTTLE	TABLET	100		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-693-01	EA - Each	16714-693	a1123c42-5c97-4653-9751-28003234ad39	1	2013-12-02
16714-693-02	EA - Each	16714-693	bcb6645d-bb34-4bca-9703-e451cddabe6a	1	2013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUCONAZOLE	ACTIVE INGREDIENT	8VZV102JFY	FLUCONAZOLE TABLET [NORTHSTAR RX LLC]	5
FLUCONAZOLE	ACTIVE MOIETY	8VZV102JFY	FLUCONAZOLE TABLET [NORTHSTAR RX LLC]	5
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	FLUCONAZOLE TABLET [NORTHSTAR RX LLC]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FLUCONAZOLE TABLET [NORTHSTAR RX LLC]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FLUCONAZOLE TABLET [NORTHSTAR RX LLC]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	FLUCONAZOLE TABLET [NORTHSTAR RX LLC]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUCONAZOLE TABLET [NORTHSTAR RX LLC]	5
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	FLUCONAZOLE TABLET [NORTHSTAR RX LLC]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-693	FLUCONAZOLE TABLET [NORTHSTAR RX LLC]	19	Current NDC, Legacy NDC, 2 package rows	20240809_d2acccda-8068-46c1-8562-950d7f70ee06.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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluconazole	FLUCONAZOLE	Redpharm Drug	568d9f2f-3394-b972-e063-6394a90a8628	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	PD-Rx Pharmaceuticals, Inc.	6bb386b0-9dbe-40ee-b873-5215b1905920	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	St. Mary's Medical Park Pharmacy	126406ae-1fdc-df20-e063-6294a90a2718	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	A-S Medication Solutions	a995790a-8470-4c51-801a-69347151a6fe	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	REMEDYREPACK INC.	726daf35-4c03-464f-a814-cc0a715d6031	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	ASCLEMED USA INC.	2099c3a0-1911-4d4a-878a-36cf054bdd0b	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	Preferred Pharmaceuticals Inc.	eeeb82e1-d668-418e-9716-f8bcf72f80c0	2026-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	Preferred Pharmaceuticals Inc.	5cbd78cd-2cd7-4882-9902-bdb7812fbc6b	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	A-S Medication Solutions	f25f31a6-4bad-40fa-bced-695552e27afd	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	Sportpharm LLC	60f3e8af-d98f-48dd-83e6-a78315aaed22	2026-02-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	Sportpharm LLC	98ac5455-d26c-4780-a5a3-bf8d85917626	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	AvPAK	551a5c8f-57eb-2643-12c6-7c700584b49f	2026-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	Northwind Health Company, LLC	c924c51c-ed7e-7e72-e053-2995a90adcd3	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	NuCare Pharmaceuticals,Inc.	124c1ffa-08fd-eca5-e063-6294a90af0e2	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	A-S Medication Solutions	c6be26bb-af92-405b-9908-972d6e985cf0	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	NuCare Pharmaceuticals,Inc.	01df20c4-7b94-044e-e063-6394a90a406a	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	PD-Rx Pharmaceuticals, Inc.	28d53f27-a0cd-4d8d-e054-00144ff8d46c	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	REMEDYREPACK INC.	1c82929f-934b-4df4-b24f-1e5da090fd8a	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	REMEDYREPACK INC.	2bd1c038-ab82-496c-8129-3182238ad1a1	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	Proficient Rx LP	fef2222c-5d61-435e-8761-d8f3d435d6d8	2025-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731

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
197698	fluconazole 100 MG Oral Tablet	PSN	d2acccda-8068-46c1-8562-950d7f70ee06	19
197699	fluconazole 150 MG Oral Tablet	PSN	d2acccda-8068-46c1-8562-950d7f70ee06	19
197700	fluconazole 200 MG Oral Tablet	PSN	d2acccda-8068-46c1-8562-950d7f70ee06	19
197701	fluconazole 50 MG Oral Tablet	PSN	d2acccda-8068-46c1-8562-950d7f70ee06	19
197698	fluconazole 100 MG Oral Tablet	SCD	d2acccda-8068-46c1-8562-950d7f70ee06	19
197699	fluconazole 150 MG Oral Tablet	SCD	d2acccda-8068-46c1-8562-950d7f70ee06	19
197700	fluconazole 200 MG Oral Tablet	SCD	d2acccda-8068-46c1-8562-950d7f70ee06	19
197701	fluconazole 50 MG Oral Tablet	SCD	d2acccda-8068-46c1-8562-950d7f70ee06	19
197700	fluconazole 200 MG Oral Tablet	PSN	fc4fccd8-19d2-4704-afa9-9ce0ab1d2b5f	1
197700	fluconazole 200 MG Oral Tablet	SCD	fc4fccd8-19d2-4704-afa9-9ce0ab1d2b5f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-693-01	16714069301	30 TABLET in 1 BOTTLE (16714-693-01)	30 tablet	2008-10-07	0000-00-00	No	No	Current
16714-693-02	16714069302	100 TABLET in 1 BOTTLE (16714-693-02)	100 tablet	2008-10-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluconazole Tablets USP Rx only	McKesson Corporation DBA SKY Packaging \| Legacy Pharmaceutical Packaging	2024-12-20	HUMAN PRESCRIPTION DRUG LABEL	18
Fluconazole Tablets USP Rx only	NorthStar Rx LLC \| Aurobindo Pharma Limited	2024-07-04	Human Prescription Drug Label	19
Fluconazole Tablets USP Rx only	Proficient Rx LP	2023-10-01	HUMAN PRESCRIPTION DRUG LABEL	1