Benzonatate

Product NDC
66116-487
11-digit product format
661160487
Labeler code
66116
Product ID
66116-487_f754cce8-1871-4bd6-9082-86607da9c8ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
MedVantx, Inc.
Application
ANDA040682
Marketing category
ANDA
Marketing start
2010-06-04
Marketing end
0000-00-00
Substance
BENZONATATE
Active strength
200 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
66116-487-302019-11-27C16284748780-19855d018-db7d-cd31-e053-dbdaa90ab51aBenzonatate Capsules, USP 100 mg and 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66116-487-30Benzonatate30 in 1 BOTTLECAPSULE, LIQUID FILLED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66116-487BENZONATATE CAPSULE, LIQUID FILLED [MEDVANTX, INC.]1Legacy NDC, 1 package rows20130820_f754cce8-1871-4bd6-9082-86607da9c8ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSNf754cce8-1871-4bd6-9082-86607da9c8ae1
283417benzonatate 200 MG Oral CapsuleSCDf754cce8-1871-4bd6-9082-86607da9c8ae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66116-487-306611604873030 in 1 BOTTLEHistorical