FDA.reportPublic FDA data

Benzonatate

Product NDC
53002-5892
11-digit product format
530025892
Labeler code
53002
Product ID
53002-5892_e7b483a8-6b06-4e27-a3cb-4e1ef5de3137
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA206948
Marketing category
ANDA
Marketing start
2018-12-21
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
53002-5892-12025-01-30C16284748780-12cef2736-98c6-d83d-e063-dadaa90ab31fBenzonatate Capsules, USP
53002-5892-22025-01-30C16284748780-12cef2736-98c6-d83d-e063-dadaa90ab31fBenzonatate Capsules, USP
53002-5892-32025-01-30C16284748780-12cef2736-98c6-d83d-e063-dadaa90ab31fBenzonatate Capsules, USP
53002-5892-52025-01-30C16284748780-12cef2736-98c6-d83d-e063-dadaa90ab31fBenzonatate Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-5892-1Benzonatate10 in 1 BOTTLECAPSULE101
53002-5892-2Benzonatate20 in 1 BOTTLECAPSULE201
53002-5892-3Benzonatate30 in 1 BOTTLECAPSULE301
53002-5892-5Benzonatate15 in 1 BOTTLECAPSULE151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-5892BENZONATATE CAPSULE [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 4 package rows20220331_477de03a-4439-42a3-9156-e440f1ab4421.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN477de03a-4439-42a3-9156-e440f1ab44211
197397benzonatate 100 MG Oral CapsuleSCD477de03a-4439-42a3-9156-e440f1ab44211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-5892-15300258920110 CAPSULE in 1 BOTTLE (53002-5892-1) 10 capsule2022-10-010000-00-00NoNoCurrent
53002-5892-25300258920220 CAPSULE in 1 BOTTLE (53002-5892-2) 20 capsule2022-10-010000-00-00NoNoCurrent
53002-5892-35300258920330 CAPSULE in 1 BOTTLE (53002-5892-3) 30 capsule2022-10-010000-00-00NoNoCurrent
53002-5892-55300258920515 CAPSULE in 1 BOTTLE (53002-5892-5) 15 capsule2022-10-010000-00-00NoNoCurrent