Ritonavir

Product NDC
65862-687
Requested package NDC
65862-687-16
11-digit product format
658620687
Labeler code
65862
Product ID
65862-687_dca8eddf-c54f-4b6e-b56c-19d6dd3e7e90
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
2026-12-31
Current FDA listing
Yes

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage65862-68765862-687-16UNFINISHEDActive or certified unfinished drug listing2026-08-17

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 · 14 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-0848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-0827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-098d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-1450b4072663b7…eae3003ed65e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206614-001RITONAVIRRITONAVIR100MGTABLET / ORALABRS2018-09-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A206614-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A206614-001RITONAVIR100MGTABLET / ORALABRS2018-09-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206614-001RITONAVIR100MGTABLET / ORALABRS2018-09-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-173f01610625f2…
2019-09-15 20:21 UTC2019-09A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206614-001RITONAVIR100MGTABLET / ORALAB2018-09-17e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A206614-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206614-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206614-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206614-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206614-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206614-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206614-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206614-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206614-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206614-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206614-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206614-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206614-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206614-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206614-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206614-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206614-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206614-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206614-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206614-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206614-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206614-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A206614-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206614-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206614-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206614-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A206614-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206614-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206614-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206614-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206614-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206614-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206614-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206614-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206614-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A206614-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A206614-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206614-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206614-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206614-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Ritonavir
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RITONAVIR100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O3J8G9O825Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
900575Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
11f757f1-cf48-47a8-925e-918359cbd2d4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1d2364f5-8b1e-7c9a-4518-7b359d95fa50Product name220250116
00d976a9-a12a-db3d-ac4e-27498af714cfProduct name520250115
7a5f5ac7-15c0-4d8b-bea4-b3b28cb83a8dProduct name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c8f34825-48cd-e7db-4048-c3be840a9308Product name520230123
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
d1ee4fdb-1116-417b-8889-dc05571445b3Product name120160825
f8d26468-b1dc-49d8-a188-8b5d531405efProduct name120150731
0b1bb9d1-e628-4e7c-aada-fd6532257932Product name120150416
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
96979b26-bb9a-43d8-e3a6-d69b9e9f75e5Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-687-01Ritonavir100 in 1 BOTTLETABLET, FILM COATED1008
65862-687-05Ritonavir500 in 1 BOTTLETABLET, FILM COATED5008
65862-687-30Ritonavir30 in 1 BOTTLETABLET, FILM COATED308
65862-687-99Ritonavir1000 in 1 BOTTLETABLET, FILM COATED10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-687-30EA - Each65862-68755bff334-ec1f-4b36-ae61-25f25a3ed6f612018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-687RITONAVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8Current NDC, Legacy NDC, 4 package rows20231114_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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RitonavirRITONAVIRBryant Ranch Prepackd2f8c6ba-5e06-4b03-8ca5-b4fd7e5a89252026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206614
application number: ANDA206614
RitonavirRITONAVIRNuCare Pharmaceuticals, Inc.3f92f1e2-59f4-f6c4-e063-6294a90a487b2025-09-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206614
application number: ANDA206614
RitonavirRITONAVIRAmerican Health Packaging19503bc4-3443-4ad4-aa27-437f4f3288b12024-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206614
application number: ANDA206614
RitonavirRITONAVIRAurobindo Pharma Limited11f757f1-cf48-47a8-925e-918359cbd2d42023-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206614
application number: ANDA206614
ndc (product): 65862-687

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900575ritonavir 100 MG Oral TabletPSNd2f8c6ba-5e06-4b03-8ca5-b4fd7e5a8925100
900575ritonavir 100 MG Oral TabletSCDd2f8c6ba-5e06-4b03-8ca5-b4fd7e5a8925100
900575ritonavir 100 MG Oral TabletPSN11f757f1-cf48-47a8-925e-918359cbd2d48
900575ritonavir 100 MG Oral TabletSCD11f757f1-cf48-47a8-925e-918359cbd2d48
900575ritonavir 100 MG Oral TabletPSN19503bc4-3443-4ad4-aa27-437f4f3288b15
900575ritonavir 100 MG Oral TabletSCD19503bc4-3443-4ad4-aa27-437f4f3288b15
900575ritonavir 100 MG Oral TabletPSN26a5440b-8611-c104-e063-6294a90af1fc1
900575ritonavir 100 MG Oral TabletPSN3f92f1e2-59f4-f6c4-e063-6294a90a487b1
900575ritonavir 100 MG Oral TabletSCD26a5440b-8611-c104-e063-6294a90af1fc1
900575ritonavir 100 MG Oral TabletSCD3f92f1e2-59f4-f6c4-e063-6294a90a487b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startStatus
65862-687-166586206871616000 TABLET, FILM COATED in 1 BAG (65862-687-16)08-FEB-22Current