Home NDC 33342-164 Lopinavir and Ritonavir
Product NDC 33342-164
11-digit product format 333420164
Labeler code 33342
Product ID 33342-164_d22e1dad-7061-475f-8501-84d8fbeb9751
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lopinavir and Ritonavir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA204739
Marketing category ANDA
Marketing start 2024-07-25
Substance LOPINAVIR; RITONAVIR
Active strength 200; 50 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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A204739-001 LOPINAVIR AND RITONAVIR LOPINAVIR; RITONAVIR 100MG;25MG TABLET / ORAL AB 2024-07-25 A204739-002 LOPINAVIR AND RITONAVIR LOPINAVIR; RITONAVIR 200MG;50MG TABLET / ORAL AB 2024-07-25
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 2026-09-14 22:38:34 2026-08 A204739-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2024-07-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204739-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2024-07-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204739-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2024-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204739-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2024-07-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204739-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2024-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204739-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2024-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204739-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2024-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204739-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2024-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204739-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2024-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204739-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2024-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204739-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2024-07-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204739-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2024-07-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204739-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2024-07-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204739-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2024-07-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204739-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2024-07-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204739-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2024-07-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204739-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2024-07-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204739-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2024-07-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204739-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2024-07-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204739-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2024-07-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204739-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2024-07-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204739-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2024-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204739-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2024-07-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204739-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2024-07-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204739-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2024-07-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204739-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2024-07-25 79d66fd596c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204739-001 LOPINAVIR AND RITONAVIR 100MG;25MG TABLET / ORAL AB 2024-07-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204739-002 LOPINAVIR AND RITONAVIR 200MG;50MG TABLET / ORAL AB 2024-07-25 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Lopinavir and Ritonavir
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOPINAVIR 200 mg/1 RITONAVIR 50 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 33342-164-09 Lopinavir and Ritonavir 60 in 1 BOTTLE TABLET, FILM COATED 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-164 LOPINAVIR AND RITONAVIR TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 1 Current NDC, 1 package rows 20240820_115178c8-5ee2-4d96-820e-ea8264c1ac10.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 33342-164-09 33342016409 60 TABLET, FILM COATED in 1 BOTTLE (33342-164-09) 2024-07-25 No No Current