Home NDC 72205-168 posaconazole
Product NDC 72205-168
11-digit product format 722050168
Labeler code 72205
Product ID 72205-168_0bdf77ae-3639-49c1-b7c7-533f9d073084
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name posaconazole
Dosage form TABLET, COATED
Route ORAL
Labeler Novadoz Pharmaceuticals LLC
Application ANDA218434
Marketing category ANDA
Marketing start 2025-02-24
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 A218434-001 POSACONAZOLE POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2025-02-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218434-001 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 A218434-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2025-02-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218434-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2025-02-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218434-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2025-02-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218434-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2025-02-24 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218434-001 POSACONAZOLE 100MG TABLET, DELAYED RELEASE / ORAL AB 2025-02-24 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 72205-168-60 posaconazole 60 in 1 BOTTLE TABLET, COATED 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72205-168 POSACONAZOLE TABLET, COATED [NOVADOZ PHARMACEUTICALS LLC] 1 Current NDC, 1 package rows 20250311_0bdf77ae-3639-49c1-b7c7-533f9d073084.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 72205-168-60 72205016860 60 TABLET, COATED in 1 BOTTLE (72205-168-60) 2025-04-01 No No Current