Benzonatate

Product NDC
87519-111
11-digit product format
875190111
Labeler code
87519
Product ID
87519-111_34168328-a68f-4fdc-868a-97af15703042
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Anvi Pharmaceuticals Inc
Application
ANDA211518
Marketing category
ANDA
Marketing start
2026-05-15
Substance
BENZONATATE
Active strength
150 mg/1
Pharmacologic classes
Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
5P4DHS6ENRBENZONATATE104-31-4BENZONATATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87519-111-908751901119090 CAPSULE in 1 BOTTLE (87519-111-90) 90 capsule2026-05-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
BENZONATATE CAPSULES 150 mg Capsules (benzonatate, USP)Anvi Pharmaceuticals Inc | Ascent Pharmaceuticals, Inc.2026-05-13HUMAN PRESCRIPTION DRUG LABEL1