BENZONATATE

Product NDC
43063-980
11-digit product format
430630980
Labeler code
43063
Product ID
43063-980_dc8f41a5-696b-5e65-e053-2a95a90a51fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BENZONATATE
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA040682
Marketing category
ANDA
Marketing start
2018-05-01
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc429dc2-e942-6686-8d72-b63c57e806aaProduct name520190416
d45c2ed6-126c-dd22-afd2-e29a2ecf77b9Product name320190215

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-980BENZONATATE CAPSULE [PD-RX PHARMACEUTICALS, INC.]14Legacy NDC20241019_5537a8c2-4493-43e3-89f8-91da473cae3d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-980-0143063098001100 CAPSULE in 1 BOTTLE, PLASTIC (43063-980-01) 100 capsule2019-05-060000-00-00NoNoCurrent
43063-980-304306309803030 CAPSULE in 1 BOTTLE, PLASTIC (43063-980-30) 30 capsule2020-07-130000-00-00NoNoCurrent
43063-980-8243063098082500 CAPSULE in 1 BOTTLE, PLASTIC (43063-980-82) 500 capsule2019-12-130000-00-00NoNoCurrent