Home NDC 68180-345 DARUNAVIR
Product NDC 68180-345
11-digit product format 681800345
Labeler code 68180
Product ID 68180-345_f2b03ba0-704c-447a-a7ab-b4eb00243295
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DARUNAVIR
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA202073
Marketing category ANDA
Marketing start 2023-06-01
Substance DARUNAVIR ETHANOLATE
Active strength 600 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 A202073-001 DARUNAVIR DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 A202073-002 DARUNAVIR DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29
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.
Product history page 1 of 2 · 54 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 2026-08-18 06:07:40 2026-07 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 9b2671bbb829…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 54 observed states.
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 A202073-002 PC 2023-11-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202073-002 PC 2023-11-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202073-002 PC 2023-11-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202073-002 PC 2023-11-28 a67488948f0b…
Additional Listing Data#
Finished product Yes
Brand name base DARUNAVIR
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DARUNAVIR ETHANOLATE 600 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 33O78XF0BW 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 68180-345-07 DARUNAVIR 60 in 1 BOTTLE TABLET, FILM COATED 60 24
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-345 DARUNAVIR TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 23 Current NDC, 1 package rows 20240320_56daf67e-7501-4cd5-be22-566d7997d42e.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 68180-345-07 68180034507 60 TABLET, FILM COATED in 1 BOTTLE (68180-345-07) 2023-06-01 No No Current