SUSTIVA- sustiva capsule 
Aesica Queenborough Limited

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Sustiva

Sustiva 200mg

RX ONLY SUSTIVA (EFAVIRENZ) CAPSULES ORAL

200 MG 1X90 BOTTLE

EXP. LOT

NDC # 0056047492 SAP # 1129809 QTY. 12

1 CASE X 12 BOTTLES X 90 CAPSULES

STORE AT 25 o​C (77 oF). EXCERSIONS PERMITTED TO 15 o-30 oC (59 o-86 oF).

[SEE USP CONTROLLED ROOM TEMPERATURE]

DIST. BY BRISTOL-MYERS SQUIBB COMPANY

PRINCETON, NJ08543 USA

Product of Switzerland

1374227, 1000009028

Sustiva 200

Sustiva 50mg

Sustiva 50mgRX RX ONLY SUSTIVA (EFAVIRENZ) CAPSULES ORAL

50 MG 1X30 BOTTLE

EXP. LOT

NDC # 0056047030 SAP # 1157714 QTY. 12

1 CASE X 12 BOTTLES X 30 CAPSULES

STORE AT 25 o​C (77 oF). EXCERSIONS PERMITTED TO 15 o-30 oC (59 o-86 oF).

[SEE USP CONTROLLED ROOM TEMPERATURE]

DIST. BY BRISTOL-MYERS SQUIBB COMPANY

PRINCETON, NJ08543 USA

Product of Switzerland

1374236, 1000009027

SUSTIVA 
sustiva capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43798-015
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EFAVIRENZ (UNII: JE6H2O27P8) (EFAVIRENZ - UNII:JE6H2O27P8) EFAVIRENZ50 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Colorwhite (White Body) , yellow (Gold Cap) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code SUSTIVA;50
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43798-015-0112 in 1 CASE11/30/2017
130 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA02097211/30/2017
SUSTIVA 
sustiva capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43798-016
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EFAVIRENZ (UNII: JE6H2O27P8) (EFAVIRENZ - UNII:JE6H2O27P8) EFAVIRENZ200 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
Product Characteristics
Coloryellow (Gold Capsule) Scoreno score
ShapeCAPSULESize24mm
FlavorImprint Code SUSTIVA
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43798-016-0112 in 1 CASE11/30/2017
190 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA02097211/30/2017
Labeler - Aesica Queenborough Limited (218784074)
Registrant - Aesica Queenborough Limited (210117119)
Establishment
NameAddressID/FEIBusiness Operations
Aesica Queenborough Limited218784074pack(43798-016, 43798-015) , manufacture(43798-016, 43798-015)

Revised: 11/2017
Document Id: 5f3574d9-a70d-5923-e053-2991aa0a64ed
Set id: 5f3574d9-a70c-5923-e053-2991aa0a64ed
Version: 1
Effective Time: 20171130
 
Aesica Queenborough Limited