Efavirenz

Product NDC
65862-104
11-digit product format
658620104
Labeler code
65862
Product ID
65862-104_a02dd4c8-6159-48b0-a79c-c362f1f4daf9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Efavirenz
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA078064
Marketing category
ANDA
Marketing start
2017-12-15
Substance
EFAVIRENZ
Active strength
50 mg/1
Pharmacologic classes
Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct65862-104UNFINISHEDActive or certified unfinished drug listing2026-08-17
unfinished packagepackage65862-10465862-104-39UNFINISHEDActive 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 · 40 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 21:27 UTC · source 2025-12-05unfinished productproducta6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage65862-104-39a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage65862-104-391d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage65862-104-39390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage65862-104-39e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage65862-104-39bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage65862-104-39f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage65862-104-39f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage65862-104-3968b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage65862-104-3905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage65862-104-3948b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproduct27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage65862-104-3927f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproduct8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage65862-104-398d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage65862-104-39d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproduct50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage65862-104-3950b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08unfinished productproduct906f6e251498…bf70b80e44f0…
2022-04-09 23:13 UTC · source 2022-04-08unfinished packagepackage65862-104-39906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-27unfinished productproduct6db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage65862-104-396db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-18unfinished productproduct8fc7167e32ce…e96bbc724034…
2021-02-18 23:40 UTC · source 2021-02-18unfinished packagepackage65862-104-398fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-17unfinished productproduct4184dd79f89f…545327b3e20f…
2020-12-18 03:04 UTC · source 2020-12-17unfinished packagepackage65862-104-394184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished productproduct4bd3596a7b87…5c64c6f6865f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished packagepackage65862-104-394bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05unfinished productproduct263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage65862-104-39263afe128892…91768de4ddbe…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078064-001EFAVIRENZEFAVIRENZ50MGCAPSULE / ORAL2017-12-15
A078064-002EFAVIRENZEFAVIRENZ100MGCAPSULE / ORAL2017-12-15
A078064-003EFAVIRENZEFAVIRENZ200MGCAPSULE / ORALRS2017-12-15

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078064-001EFAVIRENZ50MGCAPSULE / ORAL2017-12-15caaa826d4ba7…
2026-08-18 06:07:402026-07A078064-002EFAVIRENZ100MGCAPSULE / ORAL2017-12-15caaa826d4ba7…
2026-08-18 06:07:402026-07A078064-003EFAVIRENZ200MGCAPSULE / ORALRS2017-12-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078064-001EFAVIRENZ50MGCAPSULE / ORAL2017-12-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078064-002EFAVIRENZ100MGCAPSULE / ORAL2017-12-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078064-003EFAVIRENZ200MGCAPSULE / ORALRS2017-12-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078064-001EFAVIRENZ50MGCAPSULE / ORAL2017-12-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078064-002EFAVIRENZ100MGCAPSULE / ORAL2017-12-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078064-003EFAVIRENZ200MGCAPSULE / ORALRS2017-12-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078064-001EFAVIRENZ50MGCAPSULE / ORAL2017-12-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078064-002EFAVIRENZ100MGCAPSULE / ORAL2017-12-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078064-003EFAVIRENZ200MGCAPSULE / ORALRS2017-12-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078064-001EFAVIRENZ50MGCAPSULE / ORAL2017-12-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078064-002EFAVIRENZ100MGCAPSULE / ORAL2017-12-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078064-003EFAVIRENZ200MGCAPSULE / ORALRS2017-12-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078064-001EFAVIRENZ50MGCAPSULE / ORAL2017-12-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078064-002EFAVIRENZ100MGCAPSULE / ORAL2017-12-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078064-003EFAVIRENZ200MGCAPSULE / ORALRS2017-12-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078064-001EFAVIRENZ50MGCAPSULE / ORAL2017-12-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078064-002EFAVIRENZ100MGCAPSULE / ORAL2017-12-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078064-003EFAVIRENZ200MGCAPSULE / ORALRS2017-12-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078064-001EFAVIRENZ50MGCAPSULE / ORAL2017-12-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078064-002EFAVIRENZ100MGCAPSULE / ORAL2017-12-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078064-003EFAVIRENZ200MGCAPSULE / ORALRS2017-12-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078064-001EFAVIRENZ50MGCAPSULE / ORAL2017-12-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078064-002EFAVIRENZ100MGCAPSULE / ORAL2017-12-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078064-003EFAVIRENZ200MGCAPSULE / ORALRS2017-12-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078064-001EFAVIRENZ50MGCAPSULE / ORAL2017-12-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078064-002EFAVIRENZ100MGCAPSULE / ORAL2017-12-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078064-003EFAVIRENZ200MGCAPSULE / ORALRS2017-12-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078064-001EFAVIRENZ50MGCAPSULE / ORAL2017-12-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A078064-002EFAVIRENZ100MGCAPSULE / ORAL2017-12-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A078064-003EFAVIRENZ200MGCAPSULE / ORALRS2017-12-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078064-001EFAVIRENZ50MGCAPSULE / ORAL2017-12-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078064-002EFAVIRENZ100MGCAPSULE / ORAL2017-12-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078064-003EFAVIRENZ200MGCAPSULE / ORALRS2017-12-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078064-001EFAVIRENZ50MGCAPSULE / ORAL2017-12-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078064-002EFAVIRENZ100MGCAPSULE / ORAL2017-12-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078064-003EFAVIRENZ200MGCAPSULE / ORALRS2017-12-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078064-001EFAVIRENZ50MGCAPSULE / ORAL2017-12-151e350fbaab3a…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078064-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078064-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078064-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078064-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078064-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078064-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078064-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078064-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078064-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078064-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078064-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A078064-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078064-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078064-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A078064-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A078064-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078064-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A078064-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078064-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A078064-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078064-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A078064-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A078064-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A078064-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078064-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A078064-003AB1ea99ee380514…
2023-01-26 05:58 UTC2023-01A078064-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A078064-003AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078064-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078064-003AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078064-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A078064-003AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078064-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A078064-003AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078064-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078064-003AB1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EFAVIRENZ50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JE6H2O27P8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
205290Internal RxNorm lookup
205291Internal RxNorm lookup
205292Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4c57ad7f-321a-46c8-851a-c895466eb8e1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
649b204e-4c3b-7f17-657b-ae3f2995e611Product name720250220
14397d46-1c8c-bbf7-f4b7-5a7e59d3690fProduct name420220314
320f244d-8b4e-4893-9f14-104b2a8e0aafProduct name220201007
7ff71f22-5b66-4a3d-bf64-671893a6409dProduct name220201007
6f122144-2ceb-48fa-a906-0d2eb742717eProduct name120190624
03a109f6-6ebe-4ce1-a7d1-c1e0e0cbeb0bProduct name120180221

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-104-10Efavirenz3 in 1 CARTONCAPSULE37
65862-104-10Efavirenz10 in 1 BLISTER PACKCAPSULE107
65862-104-30Efavirenz30 in 1 BOTTLECAPSULE307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-104EFAVIRENZ CAPSULE [AUROBINDO PHARMA LIMITED]7Current NDC, Legacy NDC, 3 package rows20240104_4c57ad7f-321a-46c8-851a-c895466eb8e1.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EfavirenzEFAVIRENZAurobindo Pharma Limited4c57ad7f-321a-46c8-851a-c895466eb8e12023-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078064
application number: ANDA078064
ndc (product): 65862-104

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205291efavirenz 100 MG Oral CapsulePSN4c57ad7f-321a-46c8-851a-c895466eb8e17
205290efavirenz 200 MG Oral CapsulePSN4c57ad7f-321a-46c8-851a-c895466eb8e17
205292efavirenz 50 MG Oral CapsulePSN4c57ad7f-321a-46c8-851a-c895466eb8e17
205291efavirenz 100 MG Oral CapsuleSCD4c57ad7f-321a-46c8-851a-c895466eb8e17
205290efavirenz 200 MG Oral CapsuleSCD4c57ad7f-321a-46c8-851a-c895466eb8e17
205292efavirenz 50 MG Oral CapsuleSCD4c57ad7f-321a-46c8-851a-c895466eb8e17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-104-10658620104103 BLISTER PACK in 1 CARTON (65862-104-10) / 10 CAPSULE in 1 BLISTER PACK3 blister pack2017-12-150000-00-00NoNoCurrent
65862-104-306586201043030 CAPSULE in 1 BOTTLE (65862-104-30) 30 capsule2017-12-150000-00-00NoNoCurrent
65862-104-39658620104393000 CAPSULE in 1 BAG (65862-104-39)3000 capsule15-DEC-17Current