r, D,L-Malic Acid, Methylparaben
NF, Propylparaben NF, Purified Water,
Sodium Saccharin USP
sigma-tau
PHARMACEUTICALS, INC.
Avoid excess heat. Protect from freezing.
Store at controlled room temperature (25°C).
See USP.
Dosage: See package insert. Rx only.
REV. 173:00 05/07 OSFL(H)-1
MFD by: Hi-Tech Pharmacal Co., Inc.
Amityville, NY 11701
Bottle Label
CARNITOR SF
levocarnitine solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:54482-148
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOCARNITINE (LEVOCARNITINE) LEVOCARNITINE 1 g in 10 mL
Inactive Ingredients
Ingredient Name Strength
MALIC ACID
WATER
SACCHARIN SODIUM DIHYDRATE
METHYLPARABEN
PROPYLPARABEN
Product Characteristics
Color Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
Item Code Package Description
1 NDC:54482-148-01 24 BOTTLE, PLASTIC in 1 CASE
1 118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019257 04/10/1986
Labeler - Sigma-Tau Pharmaceuticals, Inc. (068301431)
Establishment
Name Address ID/FEI Operations
Hi-Tech Pharmacal Co., Inc. 101196749 MANUFACTURE(54482-148)
Establishment
Name Address ID/FEI Operations
Biosint S.p.A. 428954135 API MANUFACTURE(54482-148)
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