FDA.reportPublic FDA data

Benzonatate

Product NDC
53002-0413
11-digit product format
530020413
Labeler code
53002
Product ID
53002-0413_4a34c0fc-541b-44ca-8d1a-3c5fc495aca3
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
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
53002-0413-12025-01-30C16284748780-12cef2736-a1f6-d83d-e063-dadaa90ab31fBenzonatate Capsules, USP
53002-0413-22025-01-30C16284748780-12cef2736-a1f6-d83d-e063-dadaa90ab31fBenzonatate Capsules, USP
53002-0413-32025-01-30C16284748780-12cef2736-a1f6-d83d-e063-dadaa90ab31fBenzonatate Capsules, USP
53002-0413-42025-01-30C16284748780-12cef2736-a1f6-d83d-e063-dadaa90ab31fBenzonatate Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-0413-1Benzonatate10 in 1 BOTTLECAPSULE101
53002-0413-2Benzonatate15 in 1 BOTTLECAPSULE151
53002-0413-3Benzonatate20 in 1 BOTTLECAPSULE201
53002-0413-4Benzonatate30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-0413BENZONATATE CAPSULE [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 4 package rows20220331_a94c345f-9701-4434-a445-1b12f711e149.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSNa94c345f-9701-4434-a445-1b12f711e1491
283417benzonatate 200 MG Oral CapsuleSCDa94c345f-9701-4434-a445-1b12f711e1491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-0413-15300204130110 CAPSULE in 1 BOTTLE (53002-0413-1) 10 capsule2022-10-010000-00-00NoNoCurrent
53002-0413-25300204130215 CAPSULE in 1 BOTTLE (53002-0413-2) 15 capsule2022-10-010000-00-00NoNoCurrent
53002-0413-35300204130320 CAPSULE in 1 BOTTLE (53002-0413-3) 20 capsule2022-10-010000-00-00NoNoCurrent
53002-0413-45300204130430 CAPSULE in 1 BOTTLE (53002-0413-4) 30 capsule2022-10-010000-00-00NoNoCurrent