Home NDC 65862-299 Fluconazole
Product NDC 65862-299
11-digit product format 658620299
Labeler code 65862
Product ID 65862-299_5305f9a9-119f-43e6-a48a-1598094d6c8f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluconazole
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA079150
Marketing category ANDA
Marketing start 2009-09-18
Substance FLUCONAZOLE
Active strength 10 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 A079150-001 FLUCONAZOLE FLUCONAZOLE 50MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 A079150-002 FLUCONAZOLE FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18
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 · 82 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 2026-02-19 14:30 UTC 2026-02 A079150-001 FLUCONAZOLE 50MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079150-002 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079150-001 FLUCONAZOLE 50MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079150-002 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079150-001 FLUCONAZOLE 50MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079150-002 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079150-001 FLUCONAZOLE 50MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079150-002 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079150-001 FLUCONAZOLE 50MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079150-002 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079150-001 FLUCONAZOLE 50MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079150-002 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079150-001 FLUCONAZOLE 50MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079150-002 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079150-001 FLUCONAZOLE 50MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079150-002 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079150-001 FLUCONAZOLE 50MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079150-002 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079150-001 FLUCONAZOLE 50MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A079150-002 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079150-001 FLUCONAZOLE 50MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079150-002 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079150-001 FLUCONAZOLE 50MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079150-002 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079150-001 FLUCONAZOLE 50MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079150-002 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079150-001 FLUCONAZOLE 50MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A079150-002 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079150-001 FLUCONAZOLE 50MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079150-002 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079150-001 FLUCONAZOLE 50MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A079150-002 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079150-001 FLUCONAZOLE 50MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A079150-002 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079150-001 FLUCONAZOLE 50MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A079150-002 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079150-001 FLUCONAZOLE 50MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A079150-002 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079150-001 FLUCONAZOLE 50MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A079150-002 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2009-09-18 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Fluconazole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUCONAZOLE 10 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 310352 Internal RxNorm lookup 310353 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 65862-299-35 Fluconazole 1 in 1 CARTON POWDER, FOR SUSPENSION 1 26 65862-299-35 Fluconazole 35 mL in 1 BOTTLE POWDER, FOR SUSPENSION 35 26
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUCONAZOLE ACTIVE INGREDIENT 8VZV102JFY FLUCONAZOLE POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED] 12 FLUCONAZOLE ACTIVE MOIETY 8VZV102JFY FLUCONAZOLE POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED] 12 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL FLUCONAZOLE POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED] 12 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FLUCONAZOLE POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED] 12 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU FLUCONAZOLE POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED] 12 SUCROSE INACTIVE INGREDIENT C151H8M554 FLUCONAZOLE POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED] 12 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FLUCONAZOLE POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED] 12 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K FLUCONAZOLE POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED] 12 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE FLUCONAZOLE POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-299 FLUCONAZOLE POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED] 26 Current NDC, Legacy NDC, 2 package rows 20240814_bf588f7e-89de-4b4e-8d33-c1ff2be1b34e.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 · 3 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 65862-299-35 65862029935 1 BOTTLE in 1 CARTON (65862-299-35) / 35 mL in 1 BOTTLE 1 bottle 2009-09-18 0000-00-00 No No Current