FDA.reportPublic FDA data

SUSTIVA

Product NDC
0056-0510
11-digit product format
000560510
Labeler code
0056
Product ID
0056-0510_41a64d5a-31b4-47ba-b508-83ad0aa316f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
efavirenz
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bristol-Myers Squibb Pharma Company
Application
NDA021360
Marketing category
NDA
Marketing start
2002-02-01
Marketing end
2023-03-31
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
0000-00-00
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0056-0510-30EA - Each0056-05107872fb04-7313-430b-aea3-11f4dbbc772412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
efavirenzACTIVE INGREDIENTJE6H2O27P8SUSTIVA (EFAVIRENZ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
efavirenzACTIVE MOIETYJE6H2O27P8SUSTIVA (EFAVIRENZ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
carnauba waxINACTIVE INGREDIENTR12CBM0EIZSUSTIVA (EFAVIRENZ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61USUSTIVA (EFAVIRENZ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48SUSTIVA (EFAVIRENZ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PSUSTIVA (EFAVIRENZ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XSUSTIVA (EFAVIRENZ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30SUSTIVA (EFAVIRENZ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JSUSTIVA (EFAVIRENZ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349477efavirenz 600 MG Oral TabletPSN04b5c345-c446-43a4-83f0-509bc287e10b2
352143SUSTIVA 600 MG Oral TabletPSN04b5c345-c446-43a4-83f0-509bc287e10b2
352143efavirenz 600 MG Oral Tablet [Sustiva]SBD04b5c345-c446-43a4-83f0-509bc287e10b2
349477efavirenz 600 MG Oral TabletSCD04b5c345-c446-43a4-83f0-509bc287e10b2
352143Sustiva 600 MG Oral TabletSY04b5c345-c446-43a4-83f0-509bc287e10b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0056-0510-300005605103030 TABLET, FILM COATED in 1 BOTTLE (0056-0510-30) 2002-01-020000-00-00NoNoCurrent