Ritonavir

Product NDC: 0054-0407
Requested package NDC: 0054-0407-13
11-digit product format: 000540407
Labeler code: 0054
Product ID: 0054-0407_ec8d993c-1d1e-4c8d-83d9-87f6048b1902
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ritonavir
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: West-Ward Pharmaceuticals Corp.
Application: ANDA202573
Marketing category: ANDA
Marketing start: 2018-03-20
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0054-0407	0054-0407-13	D	Discontinued by firm		2026-10-05

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A202573-001	RITONAVIR	100MG	TABLET / ORAL	AB	2015-01-15	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202573-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202573-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202573-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202573-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202573-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202573-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202573-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202573-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202573-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202573-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202573-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202573-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202573-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202573-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202573-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202573-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202573-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202573-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202573-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202573-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202573-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202573-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202573-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202573-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202573-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202573-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202573-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202573-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202573-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202573-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202573-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202573-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202573-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202573-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202573-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202573-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202573-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202573-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202573-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202573-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0054-0407-13	2022-02-25	These highlights do not include all the information needed to use RITONAVIR TABLETS safely and effectively. See full prescribing information for RITONAVIR TABLETS. RITONAVIR tablets, for oral use Initial U.S. Approval: 1996
0054-0407-23	2022-02-25	These highlights do not include all the information needed to use RITONAVIR TABLETS safely and effectively. See full prescribing information for RITONAVIR TABLETS. RITONAVIR tablets, for oral use Initial U.S. Approval: 1996
0054-0407-13	2022-01-28	These highlights do not include all the information needed to use RITONAVIR TABLETS safely and effectively. See full prescribing information for RITONAVIR TABLETS. RITONAVIR tablets, for oral use Initial U.S. Approval: 1996
0054-0407-23	2022-01-28	These highlights do not include all the information needed to use RITONAVIR TABLETS safely and effectively. See full prescribing information for RITONAVIR TABLETS. RITONAVIR tablets, for oral use Initial U.S. Approval: 1996

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-0407-13	EA - Each	0054-0407	776d2475-5a3b-4082-b48f-c5ab7dda0193	1	2018-04-19

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
Ritonavir film coated	RITONAVIR 100 MG	Cipla USA Inc.	4633c6ba-168d-426f-acae-7843e167743a	2023-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202573 application number: ANDA202573

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O3J8G9O825	RITONAVIR	155213-67-5	RITONAVIR

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-0407-13	00054040713	30 TABLET, FILM COATED in 1 BOTTLE (0054-0407-13)	2018-03-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ritonavir	West-Ward Pharmaceuticals Corp. \| Cipla Limited	2023-12-20	HUMAN PRESCRIPTION DRUG LABEL	10
Ritonavir	REMEDYREPACK INC.	2019-08-14	HUMAN PRESCRIPTION DRUG LABEL	3
Ritonavir	American Health Packaging	2018-04-26	HUMAN PRESCRIPTION DRUG LABEL	1