FDA Product

Loxapine

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Loxapine

FDA Product Code

70518-0347

Regulatory Information

NDC Product Code

70518-0347

Application Number

ANDA072206

Marketing Category

C73584

Effective Date

January 4, 2024

Territorial Authority

USA

FDA Title

Loxapine Capsules

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

11

Company Information

ManufacturerREMEDYREPACK INC.

DUNS Number

829572556

Active Ingredients

LOXAPINE SUCCINATE

Quantity: 25 mg in 1 1

Code: X59SG0MRYU

Class Code: ACTIM

Inactive Ingredients

BUTYLPARABEN

Code: 3QPI1U3FV8

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

EDETATE CALCIUM DISODIUM

Code: 25IH6R4SGF

Class Code: IACT

METHYLPARABEN

Code: A2I8C7HI9T

Class Code: IACT

POLACRILIN POTASSIUM

Code: 0BZ5A00FQU

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

SODIUM PROPIONATE

Code: DK6Y9P42IN

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

BENZYL ALCOHOL

Code: LKG8494WBH

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

PROPYLPARABEN

Code: Z8IX2SC1OH

Class Code: IACT

Active Moieties

LOXAPINE

Code: LER583670J

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