Home NDC 42385-933 Lopinavir and Ritonavir
Product NDC 42385-933
11-digit product format 423850933
Labeler code 42385
Product ID 42385-933_3a3c4164-da47-427d-9f12-6d1f73b0729d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lopinavir and Ritonavir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Laurus Labs Limited
Application ANDA213857
Marketing category ANDA
Marketing start 2022-03-22
Substance LOPINAVIR; RITONAVIR
Active strength 100; 25 mg/1; mg/1
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]
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 1 .
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 A213857-001 LOPINAVIR AND RITONAVIR LOPINAVIR; RITONAVIR 100MG;25MG TABLET / ORAL AB 2022-03-21 A213857-002 LOPINAVIR AND RITONAVIR LOPINAVIR; RITONAVIR 200MG;50MG TABLET / ORAL AB 2022-03-21
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 · 60 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 2026-02-19 14:30 UTC 2026-02 A213857-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2022-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213857-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2022-03-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213857-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2022-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213857-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2022-03-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213857-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2022-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213857-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2022-03-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213857-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2022-03-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213857-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2022-03-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213857-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2022-03-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213857-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2022-03-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213857-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2022-03-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213857-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2022-03-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213857-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2022-03-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213857-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2022-03-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213857-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2022-03-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213857-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2022-03-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213857-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2022-03-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213857-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2022-03-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213857-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2022-03-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213857-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2022-03-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213857-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2022-03-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213857-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2022-03-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213857-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2022-03-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213857-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2022-03-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213857-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2022-03-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213857-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2022-03-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213857-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2022-03-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213857-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2022-03-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213857-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2022-03-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213857-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2022-03-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213857-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2022-03-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A213857-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2022-03-21 5d02ea3f76ae…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213857-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2022-03-21 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213857-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2022-03-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213857-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2022-03-21 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A213857-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2022-03-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213857-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2022-03-21 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A213857-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2022-03-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213857-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2022-03-21 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213857-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2022-03-21 a72a2bbeb626…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 60 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Lopinavir and Ritonavir
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOPINAVIR 100 mg/1 RITONAVIR 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O3J8G9O825 Internal UNII lookup 2494G1JF75 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 597730 Internal RxNorm lookup 746645 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 42385-933-60 Lopinavir and Ritonavir 60 in 1 BOTTLE TABLET, FILM COATED 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42385-933 LOPINAVIR AND RITONAVIR TABLET, FILM COATED [LAURUS LABS LIMITED] 2 Current NDC, Legacy NDC, 1 package rows 20231021_a7072c60-6dbf-4125-95e7-497c05a9e6a6.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 42385-933-60 42385093360 60 TABLET, FILM COATED in 1 BOTTLE (42385-933-60) 2022-03-22 0000-00-00 No No Current