FDA.reportPublic FDA data

Efavirenz

Product NDC
31722-504
11-digit product format
317220504
Labeler code
31722
Product ID
31722-504_fbbb1836-2fa8-f7a6-e053-6394a90a8718
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Efavirenz
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA078886
Marketing category
ANDA
Marketing start
2018-04-27
Substance
EFAVIRENZ
Active strength
600 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EFAVIRENZ600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJE6H2O27P8
Rxcui349477

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
31722-504-252023-05-16C16284748780-1f386c64a-21f6-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use EFAVIRENZ TABLETS safely and effectively. See full prescribing information for EFAVIRENZ TABLETS. EFAVIRENZ tablets for oral use Initial U.S. Approval: 1998
31722-504-302023-05-16C16284748780-1f386c64a-21f6-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use EFAVIRENZ TABLETS safely and effectively. See full prescribing information for EFAVIRENZ TABLETS. EFAVIRENZ tablets for oral use Initial U.S. Approval: 1998
31722-504-252023-01-30C16284748780-1f386c64a-21f6-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use EFAVIRENZ TABLETS safely and effectively. See full prescribing information for EFAVIRENZ TABLETS. EFAVIRENZ tablets for oral use Initial U.S. Approval: 1998
31722-504-302023-01-30C16284748780-1f386c64a-21f6-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use EFAVIRENZ TABLETS safely and effectively. See full prescribing information for EFAVIRENZ TABLETS. EFAVIRENZ tablets for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-504-25Efavirenz250 in 1 BOTTLETABLET, FILM COATED2503
31722-504-30Efavirenz30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-504-30EA - Each31722-504d8a31153-f880-43d8-8f82-29508f2e949412018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-504EFAVIRENZ (EFAVIRENZ) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20230517_6d625901-fef2-4c93-9619-f8991d65413d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349477efavirenz 600 MG Oral TabletPSN6d625901-fef2-4c93-9619-f8991d65413d3
349477efavirenz 600 MG Oral TabletSCD6d625901-fef2-4c93-9619-f8991d65413d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-504-2531722050425250 TABLET, FILM COATED in 1 BOTTLE (31722-504-25) 2018-04-270000-00-00NoNoCurrent
31722-504-303172205043030 TABLET, FILM COATED in 1 BOTTLE (31722-504-30) 2018-04-270000-00-00NoNoCurrent