Benzonatate

Product NDC
68071-2562
11-digit product format
680712562
Labeler code
68071
Product ID
68071-2562_235c6dec-d33c-929e-e063-6394a90a57ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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
68071-2562-26807125620221 CAPSULE in 1 BOTTLE (68071-2562-2) 21 capsule2024-09-30NoNoHistorical
68071-2562-36807125620330 CAPSULE in 1 BOTTLE (68071-2562-3) 30 capsule2021-11-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
BENZONATATE CAPSULES 100 mg Capsules 150 mg Capsules 200 mg Capsules (benzonatate, USP)NuCare Pharmaceuticals,Inc.2024-09-30HUMAN PRESCRIPTION DRUG LABEL5