Benzonatate

Product NDC
68084-214
11-digit product format
680840214
Labeler code
68084
Product ID
68084-214_235a2641-ce68-1f9c-e063-6394a90ac8a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA040597
Marketing category
ANDA
Marketing start
2021-05-26
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
68084-214-016808402140110 BLISTER PACK in 1 CARTON (68084-214-01) / 10 CAPSULE in 1 BLISTER PACK (68084-214-11) 10 blister pack2021-05-26NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Benzonatate Capsules, USP 8221401/0924 Rx onlyAmerican Health Packaging2024-09-30HUMAN PRESCRIPTION DRUG LABEL5