Home NDC 69097-655 Ritonavir
Product NDC 69097-655
11-digit product format 690970655
Labeler code 69097
Product ID 69097-655_eeb20aab-f62a-4d80-92d1-2d6b3e2a5758
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ritonavir 100 mg
Dosage form TABLET
Route ORAL
Labeler Cipla USA Inc.
Application ANDA202573
Marketing category ANDA
Marketing start 2022-03-23
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 A202573-001 RITONAVIR RITONAVIR 100MG TABLET / ORAL AB 2015-01-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202573-001 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 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202573-001 RITONAVIR 100MG TABLET / ORAL AB 2015-01-15 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ritonavir
Brand name suffix film coated
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 69097-655-02 Ritonavirfilm coated 30 in 1 CONTAINER TABLET 30 2 69097-655-08 Ritonavirfilm coated 120 in 1 CONTAINER TABLET 120 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69097-655 RITONAVIR FILM COATED (RITONAVIR 100 MG) TABLET [CIPLA USA INC.] 2 Current NDC, Legacy NDC, 2 package rows 20230316_4633c6ba-168d-426f-acae-7843e167743a.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 69097-655-02 69097065502 30 TABLET in 1 CONTAINER (69097-655-02) 30 tablet 2022-03-23 0000-00-00 No No Current 69097-655-08 69097065508 120 TABLET in 1 CONTAINER (69097-655-08) 120 tablet 2022-03-23 0000-00-00 No No Current