Benzonatate

Product NDC
71335-2853
11-digit product format
713352853
Labeler code
71335
Product ID
71335-2853_38a28a3d-6db2-4c05-85eb-da71a192d8f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202765
Marketing category
ANDA
Marketing start
2015-08-10
Substance
BENZONATATE
Active strength
200 mg/1
Pharmacologic classes
Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
5P4DHS6ENRBENZONATATE104-31-4BENZONATATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2853-171335285301100 CAPSULE in 1 BOTTLE (71335-2853-1) 100 capsule2025-10-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Benzonatate Capsules USP, 100 mg and 200 mgBryant Ranch Prepack2025-10-28HUMAN PRESCRIPTION DRUG LABEL100