Home NDC 68462-904 posaconazole
Product NDC 68462-904
11-digit product format 684620904
Labeler code 68462
Product ID 68462-904_1084301f-f51a-4bf5-8d37-bd779590d5e5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name posaconazole
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler GLENMARK PHARMACEUTICALS INC., USA
Application ANDA217553
Marketing category ANDA
Marketing start 2023-12-27
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 A217553-001 POSACONAZOLE POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RS 2023-12-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217553-001 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 A217553-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RS 2023-12-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217553-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217553-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217553-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217553-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217553-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217553-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217553-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217553-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217553-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217553-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217553-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217553-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217553-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-26 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217553-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217553-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-26 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217553-001 POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RS 2023-12-26 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 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 68462-904-01 posaconazole 16.7 mL in 1 VIAL INJECTION, SOLUTION 16.7 2 68462-904-01 posaconazole 1 in 1 CARTON INJECTION, SOLUTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-904 POSACONAZOLE INJECTION, SOLUTION [GLENMARK PHARMACEUTICALS INC., USA] 1 Current NDC, 2 package rows 20231227_a2ba0343-cd17-4b23-8356-005a1dfd0b35.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68462-904-01 68462090401 1 VIAL in 1 CARTON (68462-904-01) / 16.7 mL in 1 VIAL 1 vial 2023-12-27 No No Current