MedPath
FDA Product

Benzonatate

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

Basic Information

Benzonatate

42708-171

Regulatory Information

42708-171

ANDA206948

C73584

May 15, 2023

USA

Benzonatate Capsules, USP

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

QPharma Inc

030620888

Active Ingredients

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

LECITHIN, SOYBEAN

Code: 1DI56QDM62

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

LIGHT MINERAL OIL

Code: N6K5787QVP

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

BENZONATATE

Quantity: 200 mg in 1 1

Code: 5P4DHS6ENR

Class Code: ACTIB

Active Moieties

BENZONATATE

Code: 5P4DHS6ENR

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