Benzonatate

Product NDC
42192-618
11-digit product format
421920618
Labeler code
42192
Product ID
42192-618_1dbaffc9-a0dc-467e-a95e-6d2b9e8b7ccd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Acella Pharmaceuticals, LLC
Application
ANDA091310
Marketing category
ANDA
Marketing start
2021-08-02
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-618-01EA - Each42192-618d5f266c9-506e-448c-9bd9-82d509c5c7f412021-09-07
42192-618-05EA - Each42192-61801e38028-47e7-4d2a-9a43-1f6af8658f8912021-09-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42192-618-0142192061801100 CAPSULE in 1 BOTTLE (42192-618-01) 100 capsule2021-08-020000-00-00NoNoCurrent
42192-618-0542192061805500 CAPSULE in 1 BOTTLE (42192-618-05) 500 capsule2021-08-020000-00-00NoNoCurrent