Benzonatate

Product NDC
10135-632
11-digit product format
101350632
Labeler code
10135
Product ID
10135-632_c9329297-281a-48fc-a372-b24facbe1c32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA040682
Marketing category
ANDA
Marketing start
2017-10-20
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
2018-12-31
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
10135-632-052020-01-31C16284748780-19d75b9d0-6115-f424-e053-dadaa90a57ceBenzonatate Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-632-05Benzonatate500 in 1 BOTTLECAPSULE5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-632-05EA - Each10135-63284035bf3-6343-4254-bd07-f1a848c3b8da12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-632BENZONATATE CAPSULE [MARLEX PHARMACEUTICALS INC]1Legacy NDC, 1 package rows20171021_46badb8d-f482-4b8c-9b8b-64c2c00bed71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSN46badb8d-f482-4b8c-9b8b-64c2c00bed711
283417benzonatate 200 MG Oral CapsuleSCD46badb8d-f482-4b8c-9b8b-64c2c00bed711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10135-632-0510135063205500 in 1 BOTTLEHistorical