Home NDC 25021-184-67 Fluconazole
Product NDC 25021-184
Requested package NDC 25021-184-67
11-digit product format 250210184
Labeler code 25021
Product ID 25021-184_bd560fcb-5efc-48d3-8d2c-e21f2d072215
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluconazole
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA079104
Marketing category ANDA
Marketing start 2019-10-15
Substance FLUCONAZOLE
Active strength 2 mg/mL
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A079104-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FLUCONAZOLE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RS 2009-07-30 A079104-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FLUCONAZOLE 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP RS 2009-07-30
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.
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 2026-08-01 22:54:32 2026-06 A079104-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RS 2009-07-30 a50c72e98297…2026-08-01 22:54:32 2026-06 A079104-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP RS 2009-07-30 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A079104-001 AP 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A079104-002 AP 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Fluconazole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUCONAZOLE 2 mg/mL
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 25021-184-82 Fluconazole 10 in 1 CARTON INJECTION, SOLUTION 10 8 25021-184-82 Fluconazole 1 in 1 POUCH INJECTION, SOLUTION 1 8 25021-184-87 Fluconazole 1 in 1 POUCH INJECTION, SOLUTION 1 8 25021-184-87 Fluconazole 10 in 1 CARTON INJECTION, SOLUTION 10 8 25021-184-66 Fluconazole 10 in 1 CARTON INJECTION, SOLUTION 10 6 25021-184-66 Fluconazole 1 in 1 POUCH INJECTION, SOLUTION 1 6 25021-184-67 Fluconazole 10 in 1 CARTON INJECTION, SOLUTION 10 6 25021-184-67 Fluconazole 1 in 1 POUCH INJECTION, SOLUTION 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-184 FLUCONAZOLE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 8 Current NDC, Legacy NDC, 4 package rows 20241102_02f74fe7-0649-46c5-a06a-0700cd265773.zip 25021-184 FLUCONAZOLE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 6 Current NDC, Legacy NDC, 4 package rows 20241102_c041227b-dab6-4c29-ab59-d31993d524b2.zip
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 25021-184-67 25021018467 10 POUCH in 1 CARTON (25021-184-67) / 1 BAG in 1 POUCH / 200 mL in 1 BAG 10 pouch 2019-10-15 0000-00-00 No No Current