Home NDC 0338-6046-48 Fluconazole
Product NDC 0338-6046
Requested package NDC 0338-6046-48
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 43 .
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 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FLUCONAZOLE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FLUCONAZOLE 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 86 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 2026-09-14 22:38:34 2026-08 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Fluconazole
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUCONAZOLE 200 mg/100mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1721314 Internal RxNorm lookup 1721315 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0338-6046-48 Fluconazole 100 mL in 1 BAG INJECTION, SOLUTION 100 27 0338-6046-48 Fluconazole 10 in 1 CARTON INJECTION, SOLUTION 10 27
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0338-6046 FLUCONAZOLE INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY] 26 Current NDC, Legacy NDC, 2 package rows 20250507_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0338-6046-48 00338604648 10 BAG in 1 CARTON (0338-6046-48) / 100 mL in 1 BAG 10 bag 2004-07-29 0000-00-00 No No Current