CRIXIVAN

Product NDC
53808-0661
11-digit product format
538080661
Labeler code
53808
Product ID
53808-0661_b34e05d5-b64b-42d0-a121-f5e21dfc3c1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
indinavir sulfate
Dosage form
CAPSULE
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
NDA020685
Marketing category
NDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
INDINAVIR SULFATE
Active strength
400 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53808-0661IInactivated by FDA2026-10-12
excluded packagepackage53808-066153808-0661-1IInactivated by FDA2026-10-12

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53808-0661-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53808-0661-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53808-0661-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53808-0661-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53808-0661-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53808-0661-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53808-0661-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53808-0661-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53808-0661-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53808-0661-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53808-0661-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53808-0661-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53808-0661-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53808-0661-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53808-0661-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53808-0661-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53808-0661-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53808-0661-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53808-0661-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53808-0661-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53808-0661-19bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage53808-0661-1110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020685-001CRIXIVANINDINAVIR SULFATEEQ 400MG BASECAPSULE / ORALRLD1996-03-13
N020685-003CRIXIVANINDINAVIR SULFATEEQ 200MG BASECAPSULE / ORALRLD1996-03-13
N020685-005CRIXIVANINDINAVIR SULFATEEQ 333MG BASECAPSULE / ORAL1998-12-17
N020685-006CRIXIVANINDINAVIR SULFATEEQ 100MG BASECAPSULE / ORAL2000-04-19

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020685-001CRIXIVANEQ 400MG BASECAPSULE / ORALRLD1996-03-1384e616aacf4f…
2026-09-14 22:38:342026-08N020685-003CRIXIVANEQ 200MG BASECAPSULE / ORALRLD1996-03-1384e616aacf4f…
2026-09-14 22:38:342026-08N020685-005CRIXIVANEQ 333MG BASECAPSULE / ORAL1998-12-1784e616aacf4f…
2026-09-14 22:38:342026-08N020685-006CRIXIVANEQ 100MG BASECAPSULE / ORAL2000-04-1984e616aacf4f…
2026-08-18 06:07:402026-07N020685-001CRIXIVANEQ 400MG BASECAPSULE / ORALRLD1996-03-13caaa826d4ba7…
2026-08-18 06:07:402026-07N020685-003CRIXIVANEQ 200MG BASECAPSULE / ORALRLD1996-03-13caaa826d4ba7…
2026-08-18 06:07:402026-07N020685-005CRIXIVANEQ 333MG BASECAPSULE / ORAL1998-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07N020685-006CRIXIVANEQ 100MG BASECAPSULE / ORAL2000-04-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020685-001CRIXIVANEQ 400MG BASECAPSULE / ORALRLD1996-03-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020685-003CRIXIVANEQ 200MG BASECAPSULE / ORALRLD1996-03-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020685-005CRIXIVANEQ 333MG BASECAPSULE / ORAL1998-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020685-006CRIXIVANEQ 100MG BASECAPSULE / ORAL2000-04-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020685-001CRIXIVANEQ 400MG BASECAPSULE / ORALRLD1996-03-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020685-003CRIXIVANEQ 200MG BASECAPSULE / ORALRLD1996-03-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020685-005CRIXIVANEQ 333MG BASECAPSULE / ORAL1998-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020685-006CRIXIVANEQ 100MG BASECAPSULE / ORAL2000-04-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N020685-001CRIXIVANEQ 400MG BASECAPSULE / ORALRLD1996-03-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020685-003CRIXIVANEQ 200MG BASECAPSULE / ORALRLD1996-03-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020685-005CRIXIVANEQ 333MG BASECAPSULE / ORAL1998-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020685-006CRIXIVANEQ 100MG BASECAPSULE / ORAL2000-04-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020685-001CRIXIVANEQ 400MG BASECAPSULE / ORALRLD1996-03-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020685-003CRIXIVANEQ 200MG BASECAPSULE / ORALRLD1996-03-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020685-005CRIXIVANEQ 333MG BASECAPSULE / ORAL1998-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020685-006CRIXIVANEQ 100MG BASECAPSULE / ORAL2000-04-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020685-001CRIXIVANEQ 400MG BASECAPSULE / ORALRLD1996-03-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020685-003CRIXIVANEQ 200MG BASECAPSULE / ORALRLD1996-03-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020685-005CRIXIVANEQ 333MG BASECAPSULE / ORAL1998-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020685-006CRIXIVANEQ 100MG BASECAPSULE / ORAL2000-04-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020685-001CRIXIVANEQ 400MG BASECAPSULE / ORALRLD1996-03-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020685-003CRIXIVANEQ 200MG BASECAPSULE / ORALRLD1996-03-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020685-005CRIXIVANEQ 333MG BASECAPSULE / ORAL1998-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020685-006CRIXIVANEQ 100MG BASECAPSULE / ORAL2000-04-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020685-001CRIXIVANEQ 400MG BASECAPSULE / ORALRLD1996-03-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020685-003CRIXIVANEQ 200MG BASECAPSULE / ORALRLD1996-03-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020685-005CRIXIVANEQ 333MG BASECAPSULE / ORAL1998-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020685-006CRIXIVANEQ 100MG BASECAPSULE / ORAL2000-04-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020685-001CRIXIVANEQ 400MG BASECAPSULE / ORALRLD1996-03-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020685-003CRIXIVANEQ 200MG BASECAPSULE / ORALRLD1996-03-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020685-005CRIXIVANEQ 333MG BASECAPSULE / ORAL1998-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020685-006CRIXIVANEQ 100MG BASECAPSULE / ORAL2000-04-195bbf6a4d5a75…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N020685-00166897612021-02-10U-55474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020685-00366897612021-02-10U-55474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020685-00566897612021-02-10U-55474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020685-00666897612021-02-10U-55474a2ff9319b5…
2021-12-28 21:50 UTC2021-12N020685-00166897612021-02-10U-554782e0a99824c…
2021-12-28 21:50 UTC2021-12N020685-00366897612021-02-10U-554782e0a99824c…
2021-12-28 21:50 UTC2021-12N020685-00566897612021-02-10U-554782e0a99824c…
2021-12-28 21:50 UTC2021-12N020685-00666897612021-02-10U-554782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020685-00166897612021-02-10U-55487673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020685-00366897612021-02-10U-55487673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020685-00566897612021-02-10U-55487673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020685-00666897612021-02-10U-55487673890dc5c…
2021-03-12 10:30 UTC2021-03N020685-00166897612021-02-10U-5545aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020685-00366897612021-02-10U-5545aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020685-00566897612021-02-10U-5545aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020685-00666897612021-02-10U-5545aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020685-00166897612021-02-10U-5548869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020685-00366897612021-02-10U-5548869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020685-00566897612021-02-10U-5548869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020685-00666897612021-02-10U-5548869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020685-00166897612021-02-10U-554c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020685-00366897612021-02-10U-554c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020685-00566897612021-02-10U-554c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020685-00666897612021-02-10U-554c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020685-00166897612021-02-10U-5543f01610625f2…
2019-12-14 00:12 UTC2019-12N020685-00366897612021-02-10U-5543f01610625f2…
2019-12-14 00:12 UTC2019-12N020685-00566897612021-02-10U-5543f01610625f2…
2019-12-14 00:12 UTC2019-12N020685-00666897612021-02-10U-5543f01610625f2…
2019-09-15 20:21 UTC2019-09N020685-00166897612021-02-10U-554b00525d2431f…
2019-09-15 20:21 UTC2019-09N020685-00366897612021-02-10U-554b00525d2431f…
2019-09-15 20:21 UTC2019-09N020685-00566897612021-02-10U-554b00525d2431f…
2019-09-15 20:21 UTC2019-09N020685-00666897612021-02-10U-554b00525d2431f…
2019-07-19 19:46 UTC2019-07N020685-00166897612021-02-10U-554ea99ee380514…
2019-07-19 19:46 UTC2019-07N020685-00366897612021-02-10U-554ea99ee380514…
2019-07-19 19:46 UTC2019-07N020685-00566897612021-02-10U-554ea99ee380514…
2019-07-19 19:46 UTC2019-07N020685-00666897612021-02-10U-554ea99ee380514…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
eed3583e-78db-412f-aba7-02811a2dc6a8Product name120150204

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0661-12019-10-21C16284748780-1956f9ecf-cda4-621f-e053-dbdaa90a74adCRIXIVAN ® (INDINAVIR SULFATE) CAPSULES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0661-1CRIXIVAN30 in 1 BLISTER PACKCAPSULE303

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0661CRIXIVAN (INDINAVIR SULFATE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]3Legacy NDC, 1 package rows20100819_702727cb-3eff-425b-9573-031332849430.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
153128Crixivan 400 MG Oral CapsulePSN702727cb-3eff-425b-9573-0313328494303
310988indinavir sulfate 400 MG Oral CapsulePSN702727cb-3eff-425b-9573-0313328494303
153128indinavir 400 MG Oral Capsule [Crixivan]SBD702727cb-3eff-425b-9573-0313328494303
310988indinavir 400 MG Oral CapsuleSCD702727cb-3eff-425b-9573-0313328494303
153128Crixivan 400 MG (as indinavir sulfate 500 MG) Oral CapsuleSY702727cb-3eff-425b-9573-0313328494303
153128Crixivan 400 MG Oral CapsuleSY702727cb-3eff-425b-9573-0313328494303
310988indinavir 400 MG (indinavir sulfate 500 MG) Oral CapsuleSY702727cb-3eff-425b-9573-0313328494303

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0661-15380806610130 in 1 BLISTER PACKHistorical