Home NDC 60219-1145 Darunavir
Product NDC 60219-1145
11-digit product format 602191145
Labeler code 60219
Product ID 60219-1145_7fb8acac-13ca-47ca-8b06-d12900d4943b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Darunavir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA212493
Marketing category ANDA
Marketing start 2023-12-09
Substance DARUNAVIR
Active strength 800 mg/1
Pharmacologic classes Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]
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 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212493-001 DARUNAVIR DARUNAVIR 600MG TABLET / ORAL AB 2023-12-08 A212493-002 DARUNAVIR DARUNAVIR 800MG TABLET / ORAL AB 2023-12-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2026-08-18 06:07:40 2026-07 A212493-001 DARUNAVIR 600MG TABLET / ORAL AB 2023-12-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212493-002 DARUNAVIR 800MG TABLET / ORAL AB 2023-12-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212493-001 DARUNAVIR 600MG TABLET / ORAL AB 2023-12-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212493-002 DARUNAVIR 800MG TABLET / ORAL AB 2023-12-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212493-001 DARUNAVIR 600MG TABLET / ORAL AB 2023-12-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212493-002 DARUNAVIR 800MG TABLET / ORAL AB 2023-12-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212493-001 DARUNAVIR 600MG TABLET / ORAL AB 2023-12-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212493-002 DARUNAVIR 800MG TABLET / ORAL AB 2023-12-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212493-001 DARUNAVIR 600MG TABLET / ORAL AB 2023-12-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212493-002 DARUNAVIR 800MG TABLET / ORAL AB 2023-12-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212493-001 DARUNAVIR 600MG TABLET / ORAL AB 2023-12-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212493-002 DARUNAVIR 800MG TABLET / ORAL AB 2023-12-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212493-001 DARUNAVIR 600MG TABLET / ORAL AB 2023-12-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212493-002 DARUNAVIR 800MG TABLET / ORAL AB 2023-12-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212493-001 DARUNAVIR 600MG TABLET / ORAL AB 2023-12-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212493-002 DARUNAVIR 800MG TABLET / ORAL AB 2023-12-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212493-001 DARUNAVIR 600MG TABLET / ORAL AB 2023-12-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212493-002 DARUNAVIR 800MG TABLET / ORAL AB 2023-12-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212493-001 DARUNAVIR 600MG TABLET / ORAL AB 2023-12-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212493-002 DARUNAVIR 800MG TABLET / ORAL AB 2023-12-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212493-001 DARUNAVIR 600MG TABLET / ORAL AB 2023-12-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212493-002 DARUNAVIR 800MG TABLET / ORAL AB 2023-12-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212493-001 DARUNAVIR 600MG TABLET / ORAL AB 2023-12-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212493-002 DARUNAVIR 800MG TABLET / ORAL AB 2023-12-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212493-001 DARUNAVIR 600MG TABLET / ORAL AB 2023-12-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212493-002 DARUNAVIR 800MG TABLET / ORAL AB 2023-12-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212493-001 DARUNAVIR 600MG TABLET / ORAL AB 2023-12-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212493-002 DARUNAVIR 800MG TABLET / ORAL AB 2023-12-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212493-001 DARUNAVIR 600MG TABLET / ORAL AB 2023-12-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212493-002 DARUNAVIR 800MG TABLET / ORAL AB 2023-12-08 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212493-001 DARUNAVIR 600MG TABLET / ORAL AB 2023-12-08 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212493-002 DARUNAVIR 800MG TABLET / ORAL AB 2023-12-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212493-001 DARUNAVIR 600MG TABLET / ORAL AB 2023-12-08 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A212493-002 DARUNAVIR 800MG TABLET / ORAL AB 2023-12-08 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212493-001 DARUNAVIR 600MG TABLET / ORAL AB 2023-12-08 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212493-002 DARUNAVIR 800MG TABLET / ORAL AB 2023-12-08 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Darunavir
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DARUNAVIR 800 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YO603Y8113 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 670026 Internal RxNorm lookup 1359269 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 60219-1145-3 Darunavir 1 in 1 CARTON TABLET, FILM COATED 1 4 60219-1145-3 Darunavir 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60219-1145 DARUNAVIR TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC] 4 Current NDC, 2 package rows 20250319_92b286d5-1ee5-435b-9e1d-2e95c7f2ec69.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 60219-1145-3 60219114503 1 BOTTLE, PLASTIC in 1 CARTON (60219-1145-3) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2023-12-09 No No Current