Home DailyMed a064a4c3-c865-49d5-af80-ddc3f4cbbbf2 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 02:21:33 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022417-001 NORVIR RITONAVIR 100MG TABLET / ORAL AB RLD 2010-02-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022417-001 AB
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 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD 2010-02-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD 2010-02-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD 2010-02-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Observed Orange Book patent history# Patent history page 1 of 2 · 48 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 N022417-001 7148359 2019-07-19 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022417-001 7148359*PED 2020-01-19 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022417-001 7364752 2020-11-10 U-688 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022417-001 7364752*PED 2021-05-10 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022417-001 8268349 2024-08-25 Drug product 2012-09-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022417-001 8399015 2024-08-25 Drug product 2013-04-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022417-001 8691878 2024-08-25 U-688 2014-06-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022417-001 8268349*PED 2025-02-25 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022417-001 8399015*PED 2025-02-25 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022417-001 8691878*PED 2025-02-25 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022417-001 8470347 2026-09-17 Drug product 2013-07-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022417-001 8470347*PED 2027-03-17 Pediatric extension 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N022417-001 7148359 2019-07-19 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022417-001 7148359*PED 2020-01-19 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022417-001 7364752 2020-11-10 U-688 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022417-001 7364752*PED 2021-05-10 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022417-001 8268349 2024-08-25 Drug product 2012-09-26 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022417-001 8399015 2024-08-25 Drug product 2013-04-08 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022417-001 8691878 2024-08-25 U-688 2014-06-10 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022417-001 8268349*PED 2025-02-25 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022417-001 8399015*PED 2025-02-25 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022417-001 8691878*PED 2025-02-25 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022417-001 8470347 2026-09-17 Drug product 2013-07-12 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022417-001 8470347*PED 2027-03-17 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022417-001 7148359 2019-07-19 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022417-001 7148359*PED 2020-01-19 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022417-001 7364752 2020-11-10 U-688 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022417-001 7364752*PED 2021-05-10 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022417-001 8268349 2024-08-25 Drug product 2012-09-26 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022417-001 8399015 2024-08-25 Drug product 2013-04-08 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022417-001 8691878 2024-08-25 U-688 2014-06-10 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022417-001 8268349*PED 2025-02-25 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022417-001 8399015*PED 2025-02-25 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022417-001 8691878*PED 2025-02-25 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022417-001 8470347 2026-09-17 Drug product 2013-07-12 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022417-001 8470347*PED 2027-03-17 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022417-001 7148359 2019-07-19 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022417-001 7148359*PED 2020-01-19 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022417-001 7364752 2020-11-10 U-688 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022417-001 7364752*PED 2021-05-10 Pediatric extension ea99ee380514…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.