Home NDC 68382-696 Ritonavir
Product NDC 68382-696
11-digit product format 683820696
Labeler code 68382
Product ID 68382-696_415d6153-5ad1-0b15-e631-937279e5838c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ritonavir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc
Application NDA022417
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2018-03-20
Marketing end 0000-00-00
Substance RITONAVIR
Active strength 100 mg/1
Pharmacologic classes 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 2020-12-31
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 68382-696-06 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 68382-696-06 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 68382-696-06 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 68382-696-06 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 68382-696-06 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 68382-696-06 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 68382-696-06 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 68382-696-06 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 68382-696-06 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 68382-696-06 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 68382-696-06 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 68382-696-06 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 42 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 2026-08-18 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…2022-09-29 23:25 UTC 2022-09 N022417-001 NORVIR 100MG TABLET / ORAL AB RLD, RS 2010-02-10 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Norvir RITONAVIR AbbVie Inc. 2849298e-de6e-47bb-8194-56e075b33fc3 2026-07-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022417 application number: NDA022417