Home DailyMed f8bd85ca-419c-43ff-9895-135da86feea2 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 03:10:44 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
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 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 · 86 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 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 70 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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.