Benzonatate

Product NDC
63629-2475
11-digit product format
636292475
Labeler code
63629
Product ID
63629-2475_373cc1d7-1f22-4851-bb40-bb5d4b0138fb
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
63629-2475-163629247501500 CAPSULE in 1 BOTTLE (63629-2475-1) 500 capsule2015-08-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Benzonatate Capsules USP, 100 mg and 200 mgBryant Ranch Prepack2023-02-24HUMAN PRESCRIPTION DRUG LABEL104