Benzonatate

Product NDC
72789-230
11-digit product format
727890230
Labeler code
72789
Product ID
72789-230_2d6c8457-a91d-08a1-e063-6294a90a2807
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA206948
Marketing category
ANDA
Marketing start
2018-12-21
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
72789-230-06727890230066 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-06) 6 capsule2022-08-16NoNoHistorical
72789-230-127278902301212 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-12) 12 capsule2022-07-21NoNoHistorical
72789-230-157278902301515 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-15) 15 capsule2022-02-02NoNoHistorical
72789-230-207278902302020 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-20) 20 capsule2022-02-16NoNoHistorical
72789-230-217278902302121 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-21) 21 capsule2022-02-02NoNoHistorical
72789-230-307278902303030 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-30) 30 capsule2022-02-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Benzonatate Capsules, USPPD-Rx Pharmaceuticals, Inc.2025-02-05HUMAN PRESCRIPTION DRUG LABEL9