Home NDC 0074-3956 Kaletra
Product NDC 0074-3956
11-digit product format 000743956
Labeler code 0074
Product ID 0074-3956_36abdfba-ddc2-43ae-9173-903d66a23b23
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lopinavir and Ritonavir
Dosage form SOLUTION
Route ORAL
Labeler AbbVie Inc.
Application NDA021251
Marketing category NDA
Marketing start 2010-06-18
Substance LOPINAVIR; RITONAVIR
Active strength 80; 20 mg/mL; mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021251-001 KALETRA LOPINAVIR; RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL RLD, RS 2000-09-15
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 · 43 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 2026-09-14 22:38:34 2026-08 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL RLD, RS 2000-09-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL RLD, RS 2000-09-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL RLD, RS 2000-09-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021251-001 KALETRA 80MG/ML;20MG/ML SOLUTION / ORAL AA RLD, RS 2000-09-15 f41ea6bd6efb…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021251-001 6911214 2021-11-28 U-895 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021251-001 8501219 2021-11-28 Drug product 2013-08-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021251-001 6911214*PED 2022-05-28 Pediatric extension 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N021251-001 6911214 2021-11-28 U-895 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021251-001 8501219 2021-11-28 Drug product 2013-08-26 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021251-001 6911214*PED 2022-05-28 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021251-001 6911214 2021-11-28 U-895 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021251-001 8501219 2021-11-28 Drug product 2013-08-26 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021251-001 6911214*PED 2022-05-28 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021251-001 6911214 2021-11-28 U-895 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021251-001 8501219 2021-11-28 Drug product 2013-08-26 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021251-001 6911214*PED 2022-05-28 Pediatric extension ea99ee380514…
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 Kaletra
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOPINAVIR 80 mg/mL RITONAVIR 20 mg/mL
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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311369 Internal RxNorm lookup 597730 Internal RxNorm lookup 746645 Internal RxNorm lookup 847741 Internal RxNorm lookup 847745 Internal RxNorm lookup 847749 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 0074-3956-46 Kaletra 160 mL in 1 BOTTLE SOLUTION 160 1700 0074-3956-46 Kaletra 1 in 1 CARTON SOLUTION 1 1700
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LOPINAVIR ACTIVE INGREDIENT 2494G1JF75 KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 RITONAVIR ACTIVE INGREDIENT O3J8G9O825 KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 LOPINAVIR ACTIVE MOIETY 2494G1JF75 KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 RITONAVIR ACTIVE MOIETY O3J8G9O825 KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 ALCOHOL INACTIVE INGREDIENT 3K9958V90M KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 AMMONIUM GLYCYRRHIZATE INACTIVE INGREDIENT 3VRD35U26C KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 COPOVIDONE K25-31 INACTIVE INGREDIENT D9C330MD8B KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 HIGH FRUCTOSE CORN SYRUP INACTIVE INGREDIENT XY6UN3QB6S KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 MENTHOL, UNSPECIFIED FORM INACTIVE INGREDIENT L7T10EIP3A KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 PEPPERMINT OIL INACTIVE INGREDIENT AV092KU4JH KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 POLYOXYL 40 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT 7YC686GQ8F KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 POVIDONES INACTIVE INGREDIENT FZ989GH94E KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 SODIUM CITRATE, UNSPECIFIED FORM INACTIVE INGREDIENT 1Q73Q2JULR KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 SORBITAN MONOLAURATE INACTIVE INGREDIENT 6W9PS8B71J KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 TALC INACTIVE INGREDIENT 7SEV7J4R1U KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 VANILLA INACTIVE INGREDIENT Q74T35078H KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567 WATER INACTIVE INGREDIENT 059QF0KO0R KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1567
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0074-3956 KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] 1700 Current NDC, Legacy NDC, 2 package rows 20240922_8290add3-4449-4e58-6c97-8fe1eec972e3.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 Units Marketing start Marketing end Sample Exclude flag Status 0074-3956-46 00074395646 1 BOTTLE in 1 CARTON (0074-3956-46) / 160 mL in 1 BOTTLE 1 bottle 2010-06-18 0000-00-00 No No Current