Home NDC 55289-947 Kaletra
Product NDC 55289-947
11-digit product format 552890947
Labeler code 55289
Product ID 55289-947_d2946a2b-6f39-6c2b-e053-2995a90a65d6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lopinavir and Ritonavir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application NDA021906
Marketing category NDA
Marketing start 2010-06-18
Marketing end 0000-00-00
Substance LOPINAVIR; RITONAVIR
Active strength 200 mg/1; mg/1
Pharmacologic classes HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],UDP Glucuronosyltransferases Inducers [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55289-947-12 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 55289-947-12 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 55289-947-12 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 55289-947-12 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55289-947-12 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55289-947-12 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55289-947-12 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55289-947-12 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55289-947-12 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 55289-947-12 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 55289-947-12 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 55289-947-12 557ba5c1ecfa…9c80585c8c6e…
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 N021906-001 KALETRA LOPINAVIR; RITONAVIR 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 N021906-002 KALETRA LOPINAVIR; RITONAVIR 100MG;25MG TABLET / ORAL AB RLD 2007-11-09
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 3 · 82 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 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021906-001 KALETRA 200MG;50MG TABLET / ORAL RLD, RS 2005-10-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 KALETRA 100MG;25MG TABLET / ORAL RLD 2007-11-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 observed states.
Observed Orange Book patent history# Patent history page 1 of 4 · 144 observed states.
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 N021906-001 7148359 2019-07-19 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 7148359*PED 2020-01-19 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 7364752 2020-11-10 U-688 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 7364752*PED 2021-05-10 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 8268349 2024-08-25 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 8399015 2024-08-25 Drug product 2013-04-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 8691878 2024-08-25 U-1513 2014-06-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 8309613 2024-12-24 U-688 2012-12-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 8268349*PED 2025-02-25 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 8399015*PED 2025-02-25 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 8691878*PED 2025-02-25 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 8309613*PED 2025-06-24 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 8470347 2026-09-17 Drug product 2013-07-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 8470347*PED 2027-03-17 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 8377952 2027-10-22 U-1372 2013-03-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 8025899 2027-12-14 Drug product 2011-10-11 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 8377952*PED 2028-04-22 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 8025899*PED 2028-06-14 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 7148359 2019-07-19 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 7148359*PED 2020-01-19 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 7364752 2020-11-10 U-688 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 7364752*PED 2021-05-10 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 8268349 2024-08-25 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 8399015 2024-08-25 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 8691878 2024-08-25 U-1513 2014-06-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 8309613 2024-12-24 U-688 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 8268349*PED 2025-02-25 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 8399015*PED 2025-02-25 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 8691878*PED 2025-02-25 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 8309613*PED 2025-06-24 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 8470347 2026-09-17 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 8470347*PED 2027-03-17 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 8377952 2027-10-22 U-1372 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 8025899 2027-12-14 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 8377952*PED 2028-04-22 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 8025899*PED 2028-06-14 Pediatric extension 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N021906-001 7148359 2019-07-19 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021906-001 7148359*PED 2020-01-19 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021906-001 7364752 2020-11-10 U-688 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021906-001 7364752*PED 2021-05-10 Pediatric extension 3f01610625f2…
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 [PD-RX PHARMACEUTICALS, INC.] 1405 RITONAVIR ACTIVE INGREDIENT O3J8G9O825 KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 1405 LOPINAVIR ACTIVE MOIETY 2494G1JF75 KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 1405 RITONAVIR ACTIVE MOIETY O3J8G9O825 KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 1405 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 1405 COPOVIDONE INACTIVE INGREDIENT D9C330MD8B KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 1405 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 1405 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 1405 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 1405 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 1405 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 1405 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 1405 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 1405 SORBITAN MONOLAURATE INACTIVE INGREDIENT 6W9PS8B71J KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 1405 TALC INACTIVE INGREDIENT 7SEV7J4R1U KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 1405 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 1405
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Kaletra LOPINAVIR AND RITONAVIR AbbVie Inc. 8290add3-4449-4e58-6c97-8fe1eec972e3 2026-07-23 Warnings, Adverse reactions Exact identifier application applno (NDA): 021906 application number: NDA021906
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55289-947-12 55289094712 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-947-12) 2011-03-03 0000-00-00 No No Current