Lorazepam (Page 3 of 3)

HOW SUPPLIED

0.5 mg White, round, flat face tablet, embossed ‘EP 904’ on one side and plain on the other side,

Bottles of 30 NDC 63739-802-41
Bottles of 60 NDC 63739-802-42
Bottles of 90 NDC 63739-802-43
Bottles of 120 NDC 63739-802-44

1 mg White, round, flat face bisected tablet, embossed ‘EP 905’ on one side and ‘1’ on the other side,

Bottles of 30 NDC 63739-803-41
Bottles of 60 NDC 63739-803-42
Bottles of 90 NDC 63739-803-43
Bottles of 120 NDC 63739-803-44

2 mg White, round, flat face bisected tablet, embossed ‘EP 906’ on one side and ‘2’ on the other side,

Bottles of 30 NDC 63739-804-41
Bottles of 60 NDC 63739-804-42
Bottles of 90 NDC 63739-804-43
Bottles of 120 NDC 63739-804-44

BOTTLES:

Keep tightly closed.

Store at controlled room temperature 20° to 25°C (68° to 77°F)

Dispense in a tight container.

Manufactured by:
Excellium Pharmaceutical, Inc.
Fairfield, NJ 07004

IS-4010985

Rev. 02

Repackaged by RxPak
Division of McKesson Corp.
Memphis, TN 38141

Distributed By:
McKesson Packaging Services
a business unit of McKesson Corporation
7101 Weddington Rd., Concord, NC 28027

Representative Packaging

Lorazepam 0.5mg bottle label
(click image for full-size original)

Representative Packaging

Lorazepam 1mg bottle label
(click image for full-size original)

Representative Packaging

Lorazepam 2mg bottle label
(click image for full-size original)

LORAZEPAM
lorazepam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-802(NDC:65084-441)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORAZEPAM (LORAZEPAM) LORAZEPAM 0.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
POLACRILIN POTASSIUM
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code EP;904
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63739-802-41 30 TABLET (TABLET) in 1 BOTTLE None
2 NDC:63739-802-42 60 TABLET (TABLET) in 1 BOTTLE None
3 NDC:63739-802-43 90 TABLET (TABLET) in 1 BOTTLE None
4 NDC:63739-802-44 120 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078203 07/01/2011
LORAZEPAM
lorazepam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-803(NDC:65084-442)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORAZEPAM (LORAZEPAM) LORAZEPAM 1 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
POLACRILIN POTASSIUM
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code EP;905
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63739-803-41 30 TABLET (TABLET) in 1 BOTTLE None
2 NDC:63739-803-42 60 TABLET (TABLET) in 1 BOTTLE None
3 NDC:63739-803-43 90 TABLET (TABLET) in 1 BOTTLE None
4 NDC:63739-803-44 120 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078203 07/01/2011
LORAZEPAM
lorazepam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-804(NDC:65084-443)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORAZEPAM (LORAZEPAM) LORAZEPAM 2 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
POLACRILIN POTASSIUM
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code EP;906
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63739-804-41 30 TABLET (TABLET) in 1 BOTTLE None
2 NDC:63739-804-42 60 TABLET (TABLET) in 1 BOTTLE None
3 NDC:63739-804-43 90 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078203 07/01/2011
Labeler — McKesson Packaging Services a business unit of McKesson Corporation (140529962)
Registrant — McKesson Packaging Services a business unit of McKesson Corporation (140529962)
Establishment
Name Address ID/FEI Operations
Rx Pak Division of McKesson Corporation 177667227 REPACK

Revised: 07/2011 McKesson Packaging Services a business unit of McKesson Corporation

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