Benzonatate

Product NDC
70518-4497
11-digit product format
705184497
Labeler code
70518
Product ID
70518-4497_41487978-45d2-3515-e063-6394a90ad27b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202765
Marketing category
ANDA
Marketing start
2025-10-10
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
70518-4497-07051844970020 CAPSULE in 1 BOTTLE, PLASTIC (70518-4497-0) 20 capsule2025-10-10NoNoHistorical
70518-4497-17051844970130 CAPSULE in 1 BOTTLE, PLASTIC (70518-4497-1) 30 capsule2025-10-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Benzonatate Capsules USP, 100 mg and 200 mgREMEDYREPACK INC.2025-10-16HUMAN PRESCRIPTION DRUG LABEL2