benzonatate

Product NDC
67296-1583
11-digit product format
672961583
Labeler code
67296
Product ID
67296-1583_9c9fd8a4-488c-75a5-e053-2995a90a626a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA040749
Marketing category
ANDA
Marketing start
2018-01-01
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
No
Listing certified through
2021-12-31
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
67296-1583-32024-08-15C16284748780-1d6a99b39-9fd5-a426-e053-dadaa90af4c2benzonatate
67296-1583-32022-01-28C16284748780-1d6a99b39-9fd5-a426-e053-dadaa90af4c2benzonatate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1583-3benzonatate30 in 1 BOTTLECAPSULE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1583BENZONATATE CAPSULE [REDPHARM DRUG, INC.]3Legacy NDC, 1 package rows20240816_6a100c5c-ec5e-29a3-e053-2991aa0aa3b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSN6a100c5c-ec5e-29a3-e053-2991aa0aa3b03
283417benzonatate 200 MG Oral CapsuleSCD6a100c5c-ec5e-29a3-e053-2991aa0aa3b03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1583-36729615830330 CAPSULE in 1 BOTTLE (67296-1583-3) 30 capsule2018-01-010000-00-00NoNoCurrent