Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate

Product NDC
31722-736
Requested package NDC
31722-736-30
11-digit product format
317220736
Labeler code
31722
Product ID
31722-736_e4da0a36-7416-0c27-e053-2995a90a99f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA203053
Marketing category
ANDA
Marketing start
2022-01-24
Substance
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength
600; 200; 300 mg/1; mg/1; 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], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]
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 43.

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
A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATEEFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203053-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-2484e616aacf4f…
2026-08-18 06:07:402026-07A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-244b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-24bb7c543d1eb4…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-24cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203053-001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2022-01-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A203053-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A203053-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203053-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203053-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203053-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203053-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203053-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203053-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203053-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203053-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203053-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203053-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203053-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203053-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203053-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203053-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203053-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203053-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203053-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A203053-001AB1bb7c543d1eb4…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203053-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203053-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203053-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203053-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203053-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203053-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203053-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203053-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203053-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203053-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203053-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203053-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203053-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203053-001AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EFAVIRENZ600 mg/1
EMTRICITABINE200 mg/1
TENOFOVIR DISOPROXIL FUMARATE300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JE6H2O27P8Internal UNII lookup
G70B4ETF4SInternal UNII lookup
OTT9J7900IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
643066Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5f261872-d705-4549-a43d-2ad6b0164dc3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33cd1557-9629-1a35-1f2f-499cf7c608bcProduct name220260305
5f93de8c-a439-4aaa-862f-7cf2524cb240Product name320250812
649b204e-4c3b-7f17-657b-ae3f2995e611Product name720250220
6286e356-28a5-4b4b-a174-76bf53b211e3Product name620250121
233e3f87-da6c-4b7d-80cb-963ca3258270Product name220240419
dc21b1c2-b0f7-7f56-b95f-dcd93cbc30a4Product name320240320
c0c98dbe-5e23-74e9-f9fc-07af05f77d95Product name820240319
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
4ef90d80-1289-4267-a2bb-01c741d1208fProduct name120230829
72dcca4e-6eae-4149-a92b-264c2a07004fProduct name120230808
1cd1fd33-94db-4c45-bd26-82773ea350a3Product name220220317
14397d46-1c8c-bbf7-f4b7-5a7e59d3690fProduct name420220314
320f244d-8b4e-4893-9f14-104b2a8e0aafProduct name220201007
7ff71f22-5b66-4a3d-bf64-671893a6409dProduct name220201007
6f122144-2ceb-48fa-a906-0d2eb742717eProduct name120190624
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
8051c8a3-aee0-45a2-a236-8ee3f9e65f67Product name120181211
a56d673d-fa42-4b0e-b5ce-e65a5eab34b7Product name120180911
03a109f6-6ebe-4ce1-a7d1-c1e0e0cbeb0bProduct name120180221
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d1784558-3c5f-4d73-8a7c-051102bb6c92Product name120160405
7fd46899-3505-4ed4-b856-6b2509a76004Product name120151123
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
0583b5e6-2e6e-c94b-9ff6-81a81ba199deProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-736-30Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-736-30EA - Each31722-73606b55539-cc60-470b-ac33-5011bb3c61df12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-736EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 1 package rows20220729_5f261872-d705-4549-a43d-2ad6b0164dc3.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
Efavirenz, Emtricitabine and Tenofovir Disoproxil FumarateEFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATECamber Pharmaceuticals, Inc.5f261872-d705-4549-a43d-2ad6b0164dc32022-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203053
application number: ANDA203053
ndc (package): 31722-736-30
ndc (product): 31722-736
ndc11 (package): 31722073630

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
643066efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletPSN5f261872-d705-4549-a43d-2ad6b0164dc31
643066efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletSCD5f261872-d705-4549-a43d-2ad6b0164dc31
643066efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSY5f261872-d705-4549-a43d-2ad6b0164dc31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-736-303172207363030 TABLET, FILM COATED in 1 BOTTLE (31722-736-30) 2022-01-240000-00-00NoNoCurrent