Home NDC 65162-061 Ritonavir
Product NDC 65162-061
11-digit product format 651620061
Labeler code 65162
Product ID 65162-061_6afba378-b2d9-4ae4-b5b3-cc8811f551d1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ritonavir
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA208890
Marketing category ANDA
Marketing start 2018-09-21
Substance RITONAVIR
Active strength 100 mg/1
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 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 A208890-001 RITONAVIR RITONAVIR 100MG TABLET / ORAL 2018-09-17
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 A208890-001 RITONAVIR 100MG TABLET / ORAL 2018-09-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208890-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Ritonavir
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RITONAVIR 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O3J8G9O825 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 900575 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 65162-061-06 Ritonavir 60 in 1 BOTTLE TABLET 60 24 65162-061-32 Ritonavir 360 in 1 BOTTLE TABLET 360 24
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-061 RITONAVIR TABLET [AMNEAL PHARMACEUTICALS LLC] 24 Current NDC, Legacy NDC, 2 package rows 20241031_a32cb2e3-d4e5-4bbf-9d88-20b2b249e779.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 65162-061-06 65162006106 60 TABLET in 1 BOTTLE (65162-061-06) 60 tablet 2018-09-21 0000-00-00 No No Current 65162-061-32 65162006132 360 TABLET in 1 BOTTLE (65162-061-32) 360 tablet 2018-09-21 0000-00-00 No No Current