Home NDC 0054-0449 posaconazole
Product NDC 0054-0449
11-digit product format 000540449
Labeler code 0054
Product ID 0054-0449_216b2666-3f04-4cb4-acea-e73ed7037a10
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name posaconazole
Dosage form SUSPENSION
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA208773
Marketing category ANDA
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 A208773-001 POSACONAZOLE POSACONAZOLE 40MG/ML SUSPENSION / ORAL AB 2020-05-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208773-001 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 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL AB 2020-05-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL AB 2020-05-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL AB 2020-05-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL AB 2020-05-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL AB 2020-05-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL AB 2020-05-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL AB 2020-05-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL AB 2020-05-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL AB 2020-05-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL AB 2020-05-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL AB 2020-05-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL AB 2020-05-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL AB 2020-05-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL AB 2020-05-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL 2020-05-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL 2020-05-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL 2020-05-15 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL 2020-05-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL 2020-05-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL 2020-05-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL 2020-05-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL 2020-05-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL AB 2020-05-15 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL AB 2020-05-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL AB 2020-05-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL AB 2020-05-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL AB 2020-05-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL AB 2020-05-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL AB 2020-05-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL AB 2020-05-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL AB 2020-05-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL AB 2020-05-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL 2020-05-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL 2020-05-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL 2020-05-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL 2020-05-15 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208773-001 POSACONAZOLE 40MG/ML SUSPENSION / ORAL AB 2020-05-15 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 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 665019 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 0054-0449-49 posaconazole 105 mL in 1 BOTTLE, GLASS SUSPENSION 105 10 0054-0449-49 posaconazole 1 in 1 CARTON SUSPENSION 1 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0449 POSACONAZOLE SUSPENSION [HIKMA PHARMACEUTICALS USA INC.] 6 Current NDC, 2 package rows 20241211_282ddea7-47d8-44e4-8806-169d7cafa951.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 0054-0449-49 00054044949 1 BOTTLE, GLASS in 1 CARTON (0054-0449-49) / 105 mL in 1 BOTTLE, GLASS 2023-03-29 No No Current