Benzonatate

Product NDC
72162-1316
11-digit product format
721621316
Labeler code
72162
Product ID
72162-1316_01c4f415-1f2d-413b-8696-85aec7791fac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211518
Marketing category
ANDA
Marketing start
2019-02-22
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
72162-1316-172162131601100 CAPSULE in 1 BOTTLE (72162-1316-1) 100 capsule2023-08-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
BENZONATATE CAPSULES 100 mg Capsules 150 mg Capsules 200 mg Capsules (benzonatate, USP)Bryant Ranch Prepack2023-08-29HUMAN PRESCRIPTION DRUG LABEL100