Home NDC 0254-1016 POSACONAZOLE
Product NDC 0254-1016
11-digit product format 002541016
Labeler code 0254
Product ID 0254-1016_15fdf050-71cb-476f-a7ce-38c40262f381
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name posaconazole
Dosage form SUSPENSION
Route ORAL
Labeler ENDO USA, Inc.
Application NDA022003
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2023-03-29
Substance POSACONAZOLE
Active strength 40 mg/mL
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 N022003-001 NOXAFIL POSACONAZOLE 40MG/ML SUSPENSION / ORAL AB RLD, RS 2006-09-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022003-001 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.
Product history page 1 of 2 · 41 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 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2006-09-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2006-09-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2006-09-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2006-09-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2006-09-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2006-09-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2006-09-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2006-09-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2006-09-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2006-09-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2006-09-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2006-09-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2006-09-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2006-09-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL RLD, RS 2006-09-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL RLD, RS 2006-09-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL RLD, RS 2006-09-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL RLD, RS 2006-09-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL RLD, RS 2006-09-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL RLD, RS 2006-09-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL RLD, RS 2006-09-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL RLD, RS 2006-09-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL RLD, RS 2006-09-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2006-09-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL RLD, RS 2006-09-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL RLD, RS 2006-09-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL RLD, RS 2006-09-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2006-09-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2006-09-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2006-09-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2006-09-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2006-09-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2006-09-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2006-09-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2006-09-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2006-09-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL RLD, RS 2006-09-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL RLD, RS 2006-09-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL RLD, RS 2006-09-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022003-001 NOXAFIL 40MG/ML SUSPENSION / ORAL RLD, RS 2006-09-15 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022003-001 8263600 2022-04-01 Drug product 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022003-001 8263600 2022-04-01 Drug product 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022003-001 8263600 2022-04-01 Drug product 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022003-001 5661151 2019-07-19 U-760 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022003-001 8263600 2022-04-01 Drug product 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022003-001 8263600 2022-04-01 Drug product bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022003-001 8263600 2022-04-01 Drug product 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022003-001 8263600 2022-04-01 Drug product 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022003-001 8263600 2022-04-01 Drug product 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022003-001 8263600 2022-04-01 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022003-001 8263600 2022-04-01 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022003-001 5661151 2019-07-19 U-760 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022003-001 8263600 2022-04-01 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022003-001 5661151 2019-07-19 U-760 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022003-001 8263600 2022-04-01 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022003-001 5661151 2019-07-19 U-760 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022003-001 8263600 2022-04-01 Drug product ea99ee380514…2023-01-26 05:58 UTC 2023-01 N022003-001 8263600 2022-04-01 Drug product 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022003-001 8263600 2022-04-01 Drug product 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022003-001 8263600 2022-04-01 Drug product f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022003-001 8263600 2022-04-01 Drug product e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022003-001 8263600 2022-04-01 Drug product cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base POSACONAZOLE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POSACONAZOLE 40 mg/mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 665019 Internal RxNorm lookup 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 0254-1016-36 POSACONAZOLE 1 in 1 CARTON SUSPENSION 1 15 0254-1016-36 POSACONAZOLE 105 mL in 1 BOTTLE, GLASS SUSPENSION 105 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0254-1016 POSACONAZOLE TABLET, COATED POSACONAZOLE SUSPENSION [ENDO USA, INC.] 13 Current NDC, 2 package rows 20240829_e031b632-8e57-4359-87bd-a5da02bdc55f.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 0254-1016-36 00254101636 1 BOTTLE, GLASS in 1 CARTON (0254-1016-36) / 105 mL in 1 BOTTLE, GLASS 2023-03-29 No No Current