Benzonatate

Product NDC
42192-617
11-digit product format
421920617
Labeler code
42192
Product ID
42192-617_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
100 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
42192-617-01EA - Each42192-6176258f409-e416-48de-8f43-f70c5bca6e1712021-09-07
42192-617-05EA - Each42192-617229f3224-5076-4a19-9dab-be4ce7e95d9612021-09-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42192-617-0142192061701100 CAPSULE in 1 BOTTLE (42192-617-01) 100 capsule2021-08-020000-00-00NoNoCurrent
42192-617-0542192061705500 CAPSULE in 1 BOTTLE (42192-617-05) 500 capsule2021-08-020000-00-00NoNoCurrent