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Levocarnitine

LEVOCARNITINE TABLETS, USP 330 mg Rx only

Approved
Approval ID

0f749812-8f02-4eeb-91d9-5dd6fc9fa159

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 8, 2023

Manufacturers
FDA

Rising Pharma Holdings, Inc.

DUNS: 835513529

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Levocarnitine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code16571-762
Application NumberANDA076858
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levocarnitine
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 14, 2023
FDA Product Classification

INGREDIENTS (5)

LEVOCARNITINEActive
Quantity: 330 mg in 1 1
Code: 0G389FZZ9M
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT

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Levocarnitine - FDA Drug Approval Details