Benzonatate

Product NDC
63629-2473
11-digit product format
636292473
Labeler code
63629
Product ID
63629-2473_1a9d043d-4d3f-442d-909a-5f1312d3fbcd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202765
Marketing category
ANDA
Marketing start
2017-09-07
Substance
BENZONATATE
Active strength
100 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
63629-2473-163629247301500 CAPSULE in 1 BOTTLE (63629-2473-1) 500 capsule2017-09-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Benzonatate Capsules USP, 100 mg and 200 mgBryant Ranch Prepack2024-08-20HUMAN PRESCRIPTION DRUG LABEL108