FDA.reportPublic FDA data

benzonatate

Product NDC
50090-3246
Requested package NDC
50090-3246-0
11-digit product format
500903246
Labeler code
50090
Product ID
50090-3246_66ba6922-869f-4e97-a95a-6cac59065924
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040749
Marketing category
ANDA
Marketing start
2017-03-22
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
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-324650090-3246-0DDiscontinued by firm2026-08-03

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3246-02023-02-07C16284748780-1f386c649-a172-0266-e053-dadaa90a7c1aBenzonatate Capsules, USP 100 mg, 150 mg and 200 mg
50090-3246-12023-02-07C16284748780-1f386c649-a172-0266-e053-dadaa90a7c1aBenzonatate Capsules, USP 100 mg, 150 mg and 200 mg
50090-3246-22023-02-07C16284748780-1f386c649-a172-0266-e053-dadaa90a7c1aBenzonatate Capsules, USP 100 mg, 150 mg and 200 mg
50090-3246-02023-01-30C16284748780-1f386c649-a172-0266-e053-dadaa90a7c1aBenzonatate Capsules, USP 100 mg, 150 mg and 200 mg
50090-3246-12023-01-30C16284748780-1f386c649-a172-0266-e053-dadaa90a7c1aBenzonatate Capsules, USP 100 mg, 150 mg and 200 mg
50090-3246-22023-01-30C16284748780-1f386c649-a172-0266-e053-dadaa90a7c1aBenzonatate Capsules, USP 100 mg, 150 mg and 200 mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3246-0EA - Each50090-3246758ad6c9-86c1-4d6d-be22-da06203606ea12019-05-02
50090-3246-1EA - Each50090-32460ba9034e-5498-423e-ac27-3c1394c5b93312019-05-02
50090-3246-2EA - Each50090-324661735a40-d6cc-4290-8594-5769aa6682b612019-05-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3246-05009032460030 CAPSULE in 1 BOTTLE (50090-3246-0) 30 capsule2017-11-060000-00-00NoNoCurrent