Home NDC 65862-687-01 Ritonavir
Product NDC 65862-687
Requested package NDC 65862-687-01
11-digit product format 658620687
Labeler code 65862
Product ID 65862-687_35e7d4f2-b970-4126-8919-0c57d01e1e7b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ritonavir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
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 2027-12-31
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Ritonavir
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RITONAVIR 100 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65862-687-01 Ritonavir 100 in 1 BOTTLE TABLET, FILM COATED 100 8 65862-687-05 Ritonavir 500 in 1 BOTTLE TABLET, FILM COATED 500 8 65862-687-30 Ritonavir 30 in 1 BOTTLE TABLET, FILM COATED 30 8 65862-687-99 Ritonavir 1000 in 1 BOTTLE TABLET, FILM COATED 1000 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-687 RITONAVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 8 Current NDC, Legacy NDC, 4 package rows 20231114_11f757f1-cf48-47a8-925e-918359cbd2d4.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 65862-687-01 65862068701 100 TABLET, FILM COATED in 1 BOTTLE (65862-687-01) 2018-09-17 0000-00-00 No No Current