Home NDC 59651-596-60 POSACONAZOLE
Product NDC 59651-596
Requested package NDC 59651-596-60
11-digit product format 596510596
Labeler code 59651
Product ID 59651-596_8c734106-02cb-47c6-89fd-e4fe1cdff758
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name POSACONAZOLE
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA217119
Marketing category ANDA
Marketing start 2024-07-18
Substance POSACONAZOLE
Active strength 100 mg/1
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217119-001 POSACONAZOLE POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217119-001 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.
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 A217119-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217119-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217119-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217119-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217119-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217119-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217119-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217119-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217119-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217119-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217119-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-18 79d66fd596c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217119-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-18 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base POSACONAZOLE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POSACONAZOLE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6TK1G07BHZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1482908 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 59651-596-60 POSACONAZOLE 60 in 1 BOTTLE TABLET, DELAYED RELEASE 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-596 POSACONAZOLE TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED] 2 Current NDC, 1 package rows 20241123_f8a26673-261c-4e8e-b1e1-9e23aaf7f285.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 Marketing start Sample Exclude flag Status 59651-596-60 59651059660 60 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-596-60) 2024-07-18 No No Current