Home NDC 42291-919 Posaconazole
Product NDC 42291-919
11-digit product format 422910919
Labeler code 42291
Product ID 42291-919_48bf9c42-5b32-629b-e063-6394a90a80b2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Posaconazole
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler AvKARE
Application ANDA216626
Marketing category ANDA
Marketing start 2023-04-20
Substance POSACONAZOLE
Active strength 100 mg/1
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
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 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 A216626-001 POSACONAZOLE POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-12-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216626-001 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 A216626-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216626-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216626-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216626-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216626-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216626-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216626-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216626-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216626-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216626-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216626-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216626-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216626-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216626-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-12-22 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216626-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-12-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216626-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-12-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216626-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-12-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216626-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-12-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216626-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-12-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216626-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-12-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216626-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-12-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216626-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-12-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216626-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-12-22 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216626-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2022-12-22 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Posaconazole
Listing expiration 2027-12-31 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 42291-919-60 Posaconazole 60 in 1 BOTTLE TABLET, DELAYED RELEASE 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-919 POSACONAZOLE TABLET, DELAYED RELEASE [AVKARE] 2 Current NDC, 1 package rows 20230426_f9c81d88-8e2c-fa53-e053-6394a90ac5c4.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 Marketing start Sample Exclude flag Status 42291-919-60 42291091960 60 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-919-60) 2023-04-20 No No Current