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Levothyroxine Sodium

Levothyroxine Sodium Tablets, USP

Approved
Approval ID

e0dcc021-0831-41dd-9750-251c2f71a614

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 14, 2017

Manufacturers
FDA

Preferred Pharmaceuticals, Inc.

DUNS: 791119022

Products 1

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

Levothyroxine Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68788-9162
Application NumberNDA021210
Product Classification
M
Marketing Category
C73594
G
Generic Name
Levothyroxine Sodium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 14, 2017
FDA Product Classification

INGREDIENTS (11)

LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 0.075 mg in 1 1
Code: 9J765S329G
Classification: ACTIR
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT

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Levothyroxine Sodium - FDA Drug Approval Details