BENZONATATE

Product NDC
67296-1768
11-digit product format
672961768
Labeler code
67296
Product ID
67296-1768_d61f5cea-3634-24fd-e053-2995a90a5c3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BENZONATATE
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA040682
Marketing category
ANDA
Marketing start
2018-05-01
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
67296-1768-72024-07-25C16284748780-11030e364-f982-111a-e063-dadaa90a10e2Benzonatate 100MG Capsules
67296-1768-72024-01-30C16284748780-11030e364-f982-111a-e063-dadaa90a10e2Benzonatate 100MG Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1768-7BENZONATATE15 in 1 BOTTLECAPSULE154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1768BENZONATATE CAPSULE [REDPHARM DRUG, INC.]4Legacy NDC, 1 package rows20240727_b2e90320-f57a-50eb-e053-2a95a90af81f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSNb2e90320-f57a-50eb-e053-2a95a90af81f4
197397benzonatate 100 MG Oral CapsuleSCDb2e90320-f57a-50eb-e053-2a95a90af81f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1768-76729617680715 CAPSULE in 1 BOTTLE (67296-1768-7) 15 capsule2018-05-010000-00-00NoNoCurrent