TEMODAL- temozolomide capsule
TEMOZOLOMIDE- temozolomide capsule
Orion Corporation, Orion Pharma

----------

TEMODAL

PRINCIPAL DISPLAY PANEL - Shipping Label - 5 MG

Consignee:

MSD INTERNATIONAL GMBH
(Puerto Rico Branch) LLC

State Road 183 KM. 2.6.
00771–201 LAS PIEDRAS
Puerto Rico

Sold–to party:

Merck Sharp & Dohme lnternational
Services B.V.
Attn. PtP Dept
Waarderweg 39
2031 BN HAARLEM
Netherlands

ORION

Delivery:
80843495

Package:
1007834109

Gross weight:
52 KG

No. of packages: 00001

Contents:

Your Material 2014660
NDC 52483-1005-0
TEMODAL 5 MG BULK

Purch.order: 4500931673
Batch: 1810663
Quantity: 81,840 EA

Mfg.date: 01.12.2017
Transp: Temp +15 – +25 °C
Storage: +15..25 °C

Exp.date: 18.05.2018

Material n/a

Purch.order:
Batch:
Quantity:

Mfg.date:
Transp:
Storage:

Exp.date:

Supplier:

Orion Salo site Joensuunkatu
24100 Salo Finland

PRINCIPAL DISPLAY PANEL - Shipping Label - 180 MG

Consignee:

MSD INTERNATIONAL GMBH
(Puerto Rico Branch) LLC

State Road 183 KM. 2.6.
00771–201 LAS PIEDRAS
Puerto Rico

Sold–to party:

Merck Sharp & Dohme lnternational
Services B.V.
Attn. PtP Dept
Waarderweg 39
2031 BN HAARLEM
Netherlands

ORION

Delivery:
80866159

Package:
1008009730

Gross weight:
54 KG

No. of packages: 00001

Contents:

Your Material 2014671
NDC 52483-1180-0
TEMODAL 180 MG BULK

Purch.order: 4500978421
Batch: 1834239
Quantity: 36,710 EA

Mfg.date: 24.04.2018
Transp: Temp +15 – +25 °C
Storage: +15..25 °C

Exp.date: 09.10.2018

Material n/a

Purch.order:
Batch:
Quantity:

Mfg.date:
Transp:
Storage:

Exp.date:

Supplier:

Orion Salo site Joensuunkatu
24100 Salo Finland

PRINCIPAL DISPLAY PANEL - Shipping Label - 20 MG

Consignee:

MSD INTERNATIONAL GMBH
(Puerto Rico Branch) LLC

State Road 183 KM. 2.6.
00771–201 LAS PIEDRAS
Puerto Rico

Sold–to party:

Merck Sharp & Dohme lnternational
Services B.V.
Attn. PtP Dept
Waarderweg 39
2031 BN HAARLEM
Netherlands

ORION

Delivery:
80869116

Package:
1008035331

Gross weight:
50 KG

No. of packages: 00001

Contents:

Your Material 2014670
NDC 52483-1020-0
TEMODAL 20 MG BULK

Purch.order: 4500981696
Batch: 1830401
Quantity: 66,898 EA

Mfg.date: 03.04.2018
Transp: Temp +15 – +25 °C
Storage: +15..25 °C

Exp.date: 18.09.2018

Material n/a

Purch.order:
Batch:
Quantity:

Mfg.date:
Transp:
Storage:

Exp.date:

Supplier:

Orion Salo site Joensuunkatu
24100 Salo Finland

PRINCIPAL DISPLAY PANEL - Shipping Label - 250 MG

Consignee:

MSD INTERNATIONAL GMBH
(Puerto Rico Branch) LLC
State Road 183 KM. 2.6.
LAS PIEDRAS
00771–2011 Puerto Rico
Puerto Rico

Sold–to party:

Merck Sharp & Dohme International
Services B.V.
Attn. PtP Dept
Waarderweg 39
2031 BN HAARLEM
Netherlands

ORION

Delivery:
80866160

Package:
1008009939

Gross weight:
41 KG

No. of packages: 00001

Contents:

Your Material 2015650 NDC 52483-1250-0
TEMODAL 250 MG BULK

Purch.order: 4500978424
Batch: 1834343
Quantity: 25,205 EA

Mfg.date: 24.04.2018
Transp: Temp +15 – +25 °C
Storage: +15..25 °C

Exp.date: 09.10.2018

Material n/a
Purch.order:
Batch:
Quantity:

Mfg.date:
Transp:
Storage:

Exp.date

Supplier:

Orion Salo site Joensuunkatu
24100 Salo Finland

TEMODAL
temozolomide capsule

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC:52483-1005
Route of Administration	NOT APPLICABLE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Temozolomide (UNII: YF1K15M17Y) (Temozolomide - UNII:YF1K15M17Y)	Temozolomide	5 mg

Ingredient Name	Strength
Inactive Ingredients
Anhydrous Lactose (UNII: 3SY5LH9PMK)
Tartaric Acid (UNII: W4888I119H)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)
Stearic Acid (UNII: 4ELV7Z65AP)
Gelatin, unspecified (UNII: 2G86QN327L)
Ferric Oxide Yellow (UNII: EX438O2MRT)
FD&C Blue No. 2 (UNII: L06K8R7DQK)
Titanium Dioxide (UNII: 15FIX9V2JP)
Sodium lauryl Sulfate (UNII: 368GB5141J)
Water (UNII: 059QF0KO0R)
Shellac (UNII: 46N107B71O)
Alcohol (UNII: 3K9958V90M)
Isopropyl Alcohol (UNII: ND2M416302)
Butyl Alcohol (UNII: 8PJ61P6TS3)
Propylene Glycol (UNII: 6DC9Q167V3)
Ammonia (UNII: 5138Q19F1X)
Ferrosoferric Oxide (UNII: XM0M87F357)
Potassium Hydroxide (UNII: WZH3C48M4T)

Product Characteristics
Color	GREEN, WHITE	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	Temodal;5;mg
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52483-1005-0	3 in 1 DRUM	01/17/2017
1		41000 in 1 BAG

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
EXPORT ONLY		01/17/2017

TEMOZOLOMIDE
temozolomide capsule

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC:52483-1180
Route of Administration	NOT APPLICABLE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Temozolomide (UNII: YF1K15M17Y) (Temozolomide - UNII:YF1K15M17Y)	Temozolomide	180 mg

Ingredient Name	Strength
Inactive Ingredients
Anhydrous Lactose (UNII: 3SY5LH9PMK)
Tartaric Acid (UNII: W4888I119H)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)
Stearic Acid (UNII: 4ELV7Z65AP)
Gelatin, unspecified (UNII: 2G86QN327L)
Ferric Oxide Yellow (UNII: EX438O2MRT)
Titanium Dioxide (UNII: 15FIX9V2JP)
Sodium lauryl Sulfate (UNII: 368GB5141J)
Water (UNII: 059QF0KO0R)
Shellac (UNII: 46N107B71O)
Alcohol (UNII: 3K9958V90M)
Isopropyl Alcohol (UNII: ND2M416302)
Butyl Alcohol (UNII: 8PJ61P6TS3)
Propylene Glycol (UNII: 6DC9Q167V3)
Ammonia (UNII: 5138Q19F1X)
Ferrosoferric Oxide (UNII: XM0M87F357)
Potassium Hydroxide (UNII: WZH3C48M4T)
Ferric Oxide Red (UNII: 1K09F3G675)

Product Characteristics
Color	ORANGE, WHITE	Score	no score
Shape	CAPSULE	Size	22mm
Flavor		Imprint Code	Temodal;180;mg
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52483-1180-0	5 in 1 DRUM	07/01/2015
1		20600 in 1 BAG

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
EXPORT ONLY		07/01/2015

TEMOZOLOMIDE
temozolomide capsule

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC:52483-1020
Route of Administration	NOT APPLICABLE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Temozolomide (UNII: YF1K15M17Y) (Temozolomide - UNII:YF1K15M17Y)	Temozolomide	20 mg

Ingredient Name	Strength
Inactive Ingredients
Anhydrous Lactose (UNII: 3SY5LH9PMK)
Tartaric Acid (UNII: W4888I119H)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)
Stearic Acid (UNII: 4ELV7Z65AP)
Gelatin, unspecified (UNII: 2G86QN327L)
Ferric Oxide Yellow (UNII: EX438O2MRT)
Titanium Dioxide (UNII: 15FIX9V2JP)
Sodium lauryl Sulfate (UNII: 368GB5141J)
Water (UNII: 059QF0KO0R)
Shellac (UNII: 46N107B71O)
Alcohol (UNII: 3K9958V90M)
Isopropyl Alcohol (UNII: ND2M416302)
Butyl Alcohol (UNII: 8PJ61P6TS3)
Propylene Glycol (UNII: 6DC9Q167V3)
Ammonia (UNII: 5138Q19F1X)
Ferrosoferric Oxide (UNII: XM0M87F357)
Potassium Hydroxide (UNII: WZH3C48M4T)

Product Characteristics
Color	YELLOW, WHITE	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	Temodal;20;mg
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52483-1020-0	4 in 1 DRUM	07/01/2015
1		47200 in 1 BAG

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
EXPORT ONLY		07/01/2015

TEMOZOLOMIDE
temozolomide capsule

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC:52483-1250
Route of Administration	NOT APPLICABLE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Temozolomide (UNII: YF1K15M17Y) (Temozolomide - UNII:YF1K15M17Y)	Temozolomide	250 mg

Ingredient Name	Strength
Inactive Ingredients
Anhydrous Lactose (UNII: 3SY5LH9PMK)
Tartaric Acid (UNII: W4888I119H)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)
Stearic Acid (UNII: 4ELV7Z65AP)
Gelatin, unspecified (UNII: 2G86QN327L)
Titanium Dioxide (UNII: 15FIX9V2JP)
Sodium lauryl Sulfate (UNII: 368GB5141J)
Water (UNII: 059QF0KO0R)
Shellac (UNII: 46N107B71O)
Alcohol (UNII: 3K9958V90M)
Isopropyl Alcohol (UNII: ND2M416302)
Butyl Alcohol (UNII: 8PJ61P6TS3)
Propylene Glycol (UNII: 6DC9Q167V3)
Ammonia (UNII: 5138Q19F1X)
Ferrosoferric Oxide (UNII: XM0M87F357)
Potassium Hydroxide (UNII: WZH3C48M4T)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	22mm
Flavor		Imprint Code	Temodal;250;mg
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52483-1250-0	5 in 1 DRUM	12/01/2018
1		4800 in 1 BAG

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
EXPORT ONLY		12/01/2018

Labeler - Orion Corporation, Orion Pharma (539763727)

Name	Address	ID/FEI	Business Operations
Establishment
Orion Corporation, Orion Pharma		537940319	MANUFACTURE(52483-1005, 52483-1020, 52483-1180, 52483-1250) , ANALYSIS(52483-1005, 52483-1020, 52483-1180, 52483-1250)

Revised: 10/2018

Document Id: 6e877ea8-9c8f-471c-a2b6-84d4d78e13db

Set id: e164f0b4-6aea-4056-bb14-e742594d5549

Version: 2

Effective Time: 20181017

Orion Corporation, Orion Pharma