Benzonatate

Product NDC
68071-2624
11-digit product format
680712624
Labeler code
68071
Product ID
68071-2624_d681870d-8f0e-2670-e053-2a95a90a5114
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA202765
Marketing category
ANDA
Marketing start
2015-08-10
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
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
68071-2624-32024-01-30C16284748780-11030e365-02f9-111a-e063-dadaa90a10e2Benzonatate Capsules USP, 100 mg and 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2624-3Benzonatate30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2624BENZONATATE CAPSULE [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20220127_d6818700-fca9-8b06-e053-2995a90a4f64.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSNd6818700-fca9-8b06-e053-2995a90a4f641
283417benzonatate 200 MG Oral CapsuleSCDd6818700-fca9-8b06-e053-2995a90a4f641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2624-36807126240330 CAPSULE in 1 BOTTLE (68071-2624-3) 30 capsule2022-01-210000-00-00NoNoCurrent