benzonatate

Product NDC
0615-8194
11-digit product format
006158194
Labeler code
0615
Product ID
0615-8194_58c844a5-dc92-4b70-9201-127a9ab2d24e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA040627
Marketing category
ANDA
Marketing start
2017-03-22
Marketing end
2023-06-30
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
0000-00-00
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8194-390061581943930 CAPSULE in 1 BLISTER PACK (0615-8194-39) 30 capsule2017-03-222023-06-30NoNoCurrent