Levorphanol Tartrate: Package Insert and Label Information (Page 4 of 4)

2 mg Bottle Label

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

3 mg Bottle Label

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

LEVORPHANOL TARTRATE levorphanol tartrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-3236
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVORPHANOL TARTRATE (LEVORPHANOL) LEVORPHANOL TARTRATE 2 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
STARCH, CORN
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code N;236
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0527-3236-37 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213479 05/20/2019
LEVORPHANOL TARTRATE levorphanol tartrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-3237
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVORPHANOL TARTRATE (LEVORPHANOL) LEVORPHANOL TARTRATE 3 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
STARCH, CORN
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 8mm
Flavor Imprint Code N237
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0527-3237-37 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213479 01/12/2020
Labeler — Lannett Company, Inc. (002277481)

Revised: 01/2021 Lannett Company, Inc.

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