FDA.reportPublic FDA data

benzonatate

Product NDC
53217-338
11-digit product format
532170338
Labeler code
53217
Product ID
53217-338_3e9d52e5-8e9f-4e8d-bc60-b6712f8744a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA040749
Marketing category
ANDA
Marketing start
2017-11-20
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
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53217-338IInactivated by FDA2026-07-31
excluded packagepackage53217-33853217-338-30IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
benzonatateBENZONATATEBryant Ranch Prepacka788cb01-6dc3-4f28-aaa0-c23ac058c39a2026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040749
application number: ANDA040749
benzonatateBENZONATATEProficient Rx LP9566b9b9-54ef-423c-8ce4-0f17140521582022-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040749
application number: ANDA040749
benzonatateBENZONATATEProficient Rx LP27156dad-64d6-4ea4-a3da-29e8e096fb012020-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040749
application number: ANDA040749

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
53217-338-302020-01-31C16284748780-19d75b9d0-3655-f424-e053-dadaa90a57ceBenzonatate Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-338-30benzonatate30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-338BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20180815_1fda0d89-1c46-4411-9565-9546995998db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSN1fda0d89-1c46-4411-9565-9546995998db1
283417benzonatate 200 MG Oral CapsuleSCD1fda0d89-1c46-4411-9565-9546995998db1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-338-305321703383030 in 1 BOTTLEHistorical