Home NDC 68071-3898 Ritonavir
Product NDC 68071-3898
11-digit product format 680713898
Labeler code 68071
Product ID 68071-3898_3f92f1e9-d808-9820-e063-6394a90aa98b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ritonavir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NuCare Pharmaceuticals, Inc.
Application ANDA206614
Marketing category ANDA
Marketing start 2018-09-17
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 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 A206614-001 RITONAVIR RITONAVIR 100MG TABLET / ORAL AB RS 2018-09-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206614-001 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 A206614-001 RITONAVIR 100MG TABLET / ORAL AB RS 2018-09-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206614-001 RITONAVIR 100MG TABLET / ORAL AB RS 2018-09-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206614-001 RITONAVIR 100MG TABLET / ORAL AB RS 2018-09-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206614-001 RITONAVIR 100MG TABLET / ORAL AB 2018-09-17 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 68071-3898-3 Ritonavir 3 in 1 BOTTLE TABLET, FILM COATED 3 1
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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ritonavir RITONAVIR Bryant Ranch Prepack d2f8c6ba-5e06-4b03-8ca5-b4fd7e5a8925 2026-03-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206614 application number: ANDA206614 Ritonavir RITONAVIR NuCare Pharmaceuticals, Inc. 3f92f1e2-59f4-f6c4-e063-6294a90a487b 2025-09-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206614 application number: ANDA206614 ndc (product): 68071-3898 Ritonavir RITONAVIR American Health Packaging 19503bc4-3443-4ad4-aa27-437f4f3288b1 2024-04-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206614 application number: ANDA206614 Ritonavir RITONAVIR Aurobindo Pharma Limited 11f757f1-cf48-47a8-925e-918359cbd2d4 2023-11-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206614 application number: ANDA206614
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68071-3898-3 68071389803 3 TABLET, FILM COATED in 1 BOTTLE (68071-3898-3) 2025-09-24 No No Current