Home NDC 42023-195 Posaconazole
Product NDC 42023-195
11-digit product format 420230195
Labeler code 42023
Product ID 42023-195_70da1db2-5881-462d-86c6-04adaac2c630
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Posaconazole
Dosage form INJECTION
Route INTRAVENOUS
Labeler Par Health USA, LLC
Application ANDA208768
Marketing category ANDA
Marketing start 2023-01-01
Substance POSACONAZOLE
Active strength 18 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 A208768-001 POSACONAZOLE POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208768-001 AP
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 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208768-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-25 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2023-12-20 04:57 UTC 2023-12 A208768-001 PC 2023-12-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208768-001 PC 2023-12-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208768-001 PC 2023-12-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208768-001 PC 2023-12-26 a67488948f0b…
Additional Listing Data#
Finished product Yes
Brand name base Posaconazole
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POSACONAZOLE 18 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1492043 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 42023-195-01 Posaconazole 1 in 1 CARTON INJECTION 1 20 42023-195-01 Posaconazole 16.7 mL in 1 VIAL, GLASS INJECTION 16.7 20
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42023-195 POSACONAZOLE INJECTION [ENDO USA, INC.] 13 Current NDC, Legacy NDC, 2 package rows 20240425_4032672e-1bb0-427d-a3b3-09cda4beaf34.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 Marketing end Sample Exclude flag Status 42023-195-01 42023019501 1 VIAL, GLASS in 1 CARTON (42023-195-01) / 16.7 mL in 1 VIAL, GLASS 2023-01-01 0000-00-00 No No Current