Benzonatate

Product NDC
42254-078
11-digit product format
422540078
Labeler code
42254
Product ID
42254-078_ce85fa92-783e-4f71-b7ae-bc0eb0410e13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA040682
Marketing category
ANDA
Marketing start
2010-01-13
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
E
Listing certified through
2017-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-078-202019-09-24C16284748780-19350213a-3de8-c013-e053-90daa90a1393Benzonatate Capsules, USP 100 mg and 200 mg
42254-078-302019-09-24C16284748780-19350213a-3de8-c013-e053-90daa90a1393Benzonatate Capsules, USP 100 mg and 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-078-20Benzonatate20 in 1 BOTTLECAPSULE, LIQUID FILLED201
42254-078-30Benzonatate30 in 1 BOTTLECAPSULE, LIQUID FILLED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-078BENZONATATE CAPSULE, LIQUID FILLED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20120420_ce85fa92-783e-4f71-b7ae-bc0eb0410e13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSNce85fa92-783e-4f71-b7ae-bc0eb0410e131
197397benzonatate 100 MG Oral CapsuleSCDce85fa92-783e-4f71-b7ae-bc0eb0410e131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-078-204225400782020 in 1 BOTTLEHistorical
42254-078-304225400783030 in 1 BOTTLEHistorical