Benzonatate

Product NDC
67296-1576
11-digit product format
672961576
Labeler code
67296
Product ID
67296-1576_d61f8a0d-5ebc-40d7-e053-2995a90a366d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA081297
Marketing category
ANDA
Marketing start
2018-01-01
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1576-52024-08-15C16284748780-11030e365-6ecd-111a-e063-dadaa90a10e2benzonatate 100
67296-1576-52024-01-30C16284748780-11030e365-6ecd-111a-e063-dadaa90a10e2benzonatate 100

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1576-5Benzonatate15 in 1 BOTTLECAPSULE156

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1576BENZONATATE CAPSULE [REDPHARM DRUG, INC.]6Legacy NDC, 1 package rows20240816_686b0e88-7a09-966b-e053-2991aa0ac9c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN686b0e88-7a09-966b-e053-2991aa0ac9c46
197397benzonatate 100 MG Oral CapsuleSCD686b0e88-7a09-966b-e053-2991aa0ac9c46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1576-56729615760515 CAPSULE in 1 BOTTLE (67296-1576-5) 15 capsule2018-01-010000-00-00NoNoCurrent