Fluconazole

Product NDC
0338-6046
11-digit product format
003386046
Labeler code
0338
Product ID
0338-6046_36e35cdf-c4a0-428a-879e-1d65e2b66f64
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Company
Application
ANDA076766
Marketing category
ANDA
Marketing start
2004-07-29
Substance
FLUCONAZOLE
Active strength
200 mg/100mL
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076766-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERFLUCONAZOLE200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-29
A076766-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERFLUCONAZOLE400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076766-001AP
A076766-002AP

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076766-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07A076766-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076766-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076766-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076766-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076766-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076766-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076766-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076766-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076766-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076766-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076766-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076766-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076766-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076766-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076766-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076766-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076766-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076766-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076766-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076766-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A076766-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076766-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076766-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076766-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076766-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076766-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076766-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076766-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076766-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076766-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076766-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076766-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076766-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076766-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076766-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076766-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076766-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076766-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076766-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2004-07-29bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076766-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A076766-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076766-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076766-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076766-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076766-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076766-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076766-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076766-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076766-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076766-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076766-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076766-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076766-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076766-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076766-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076766-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076766-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076766-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076766-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076766-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076766-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076766-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076766-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076766-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076766-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076766-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076766-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076766-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076766-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076766-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076766-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076766-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076766-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076766-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076766-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076766-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076766-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076766-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076766-002AP1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Fluconazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUCONAZOLE200 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8VZV102JFYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1721314Internal RxNorm lookup
1721315Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cd24a261-9c15-42b4-8040-89d2dbda174eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
74f0b828-cb79-42cb-bb6c-81c9f5bd2648Product name220250623
fe6bb120-ebc6-6290-9eab-e842fdb6c841Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-6046-48Fluconazole100 mL in 1 BAGINJECTION, SOLUTION10027
0338-6046-48Fluconazole10 in 1 CARTONINJECTION, SOLUTION1027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-6046-48ML - Milliliter0338-6046aad088bf-16ed-4d7d-bccf-d67d889a7e5412012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-6046FLUCONAZOLE INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY]26Current NDC, Legacy NDC, 2 package rows20250507_cd24a261-9c15-42b4-8040-89d2dbda174e.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluconazoleFLUCONAZOLEBaxter Healthcare Companycd24a261-9c15-42b4-8040-89d2dbda174e2024-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076766
application number: ANDA076766
ndc (product): 0338-6046

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1721315fluconazole 200 MG in 100 ML InjectionPSNcd24a261-9c15-42b4-8040-89d2dbda174e27
1721314fluconazole 400 MG in 200 ML InjectionPSNcd24a261-9c15-42b4-8040-89d2dbda174e27
1721315100 ML fluconazole 2 MG/ML InjectionSCDcd24a261-9c15-42b4-8040-89d2dbda174e27
1721314200 ML fluconazole 2 MG/ML InjectionSCDcd24a261-9c15-42b4-8040-89d2dbda174e27
1721315fluconazole 200 MG per 100 ML InjectionSYcd24a261-9c15-42b4-8040-89d2dbda174e27
1721314fluconazole 400 MG per 200 ML InjectionSYcd24a261-9c15-42b4-8040-89d2dbda174e27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-6046-480033860464810 BAG in 1 CARTON (0338-6046-48) / 100 mL in 1 BAG10 bag2004-07-290000-00-00NoNoCurrent