Benzonatate

Product NDC
71626-201
11-digit product format
716260201
Labeler code
71626
Product ID
71626-201_d6a5f3b3-799f-41cf-85cf-51a449196ac8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Medstone Pharma LLC
Application
ANDA202765
Marketing category
ANDA
Marketing start
2018-10-31
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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71626-201-01Benzonatate100 in 1 BOTTLECAPSULE1002
71626-201-05Benzonatate500 in 1 BOTTLECAPSULE5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71626-201-01EA - Each71626-2013d842f55-1208-48c0-8d54-9ada907d206212019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71626-201BENZONATATE CAPSULE [MEDSTONE PHARMA LLC]2Legacy NDC, 2 package rows20200401_d58b2044-918c-4626-815f-957530611495.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSNd58b2044-918c-4626-815f-9575306114952
197397benzonatate 100 MG Oral CapsuleSCDd58b2044-918c-4626-815f-9575306114952

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71626-201-0171626020101100 CAPSULE in 1 BOTTLE (71626-201-01) 100 capsule2018-10-310000-00-00NoNoCurrent
71626-201-0571626020105500 CAPSULE in 1 BOTTLE (71626-201-05) 500 capsule2018-10-310000-00-00NoNoCurrent