Home NDC 50268-683 Posaconazole
Product NDC 50268-683
11-digit product format 502680683
Labeler code 50268
Product ID 50268-683_2b4c1730-ff8e-04ea-e063-6394a90a136b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Posaconazole
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler AvPAK
Application ANDA212500
Marketing category ANDA
Marketing start 2022-05-09
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 A212500-001 POSACONAZOLE POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212500-001 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 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212500-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-04-07 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 50268-683-11 Posaconazole 1 in 1 BLISTER PACK TABLET, DELAYED RELEASE 1 2 50268-683-12 Posaconazole 20 in 1 BOX TABLET, DELAYED RELEASE 20 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50268-683 POSACONAZOLE TABLET, DELAYED RELEASE [AVPAK] 2 Current NDC, Legacy NDC, 2 package rows 20250112_de95df83-a495-1900-e053-2995a90abf24.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 · 2 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 50268-683-11 50268068311 1 in 1 BLISTER PACK Historical 50268-683-12 50268068312 20 BLISTER PACK in 1 BOX (50268-683-12) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (50268-683-11) 20 blister pack 2022-05-09 0000-00-00 No No Current