Benzonatate

Product NDC
67296-1549
11-digit product format
672961549
Labeler code
67296
Product ID
67296-1549_d61f62cf-5dab-4580-e053-2a95a90ac6aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA040597
Marketing category
ANDA
Marketing start
2007-04-09
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
67296-1549-12024-08-15C16284748780-11030e365-2ddf-111a-e063-dadaa90a10e2Benzonatate 100mg
67296-1549-12024-01-30C16284748780-11030e365-2ddf-111a-e063-dadaa90a10e2Benzonatate 100mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1549-1Benzonatate15 in 1 BOTTLECAPSULE155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1549BENZONATATE CAPSULE [REDPHARM DRUG, INC.]5Legacy NDC, 1 package rows20240816_59900776-1820-3f2a-e053-2a91aa0aa9e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN59900776-1820-3f2a-e053-2a91aa0aa9e35
197397benzonatate 100 MG Oral CapsuleSCD59900776-1820-3f2a-e053-2a91aa0aa9e35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1549-16729615490115 CAPSULE in 1 BOTTLE (67296-1549-1) 15 capsule2007-04-090000-00-00NoNoCurrent