FDA.reportPublic FDA data

benzonatate

Product NDC
63629-7647
Requested package NDC
63629-7647-3
11-digit product format
636297647
Labeler code
63629
Product ID
63629-7647_ecdf1e43-0f49-4d79-b372-be25f12159bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
2021-12-31
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 packagepackage63629-764763629-7647-3DDiscontinued 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
63629-7647-12020-10-16C16284748780-19d75b9d0-6406-f424-e053-dadaa90a57ceBenzonatate Capsules, USP 100 mg, 150 mg and 200 mg
63629-7647-22020-10-16C16284748780-19d75b9d0-6406-f424-e053-dadaa90a57ceBenzonatate Capsules, USP 100 mg, 150 mg and 200 mg
63629-7647-32020-10-16C16284748780-19d75b9d0-6406-f424-e053-dadaa90a57ceBenzonatate Capsules, USP 100 mg, 150 mg and 200 mg
63629-7647-12020-01-31C16284748780-19d75b9d0-6406-f424-e053-dadaa90a57ceBenzonatate Capsules, USP 100 mg, 150 mg and 200 mg
63629-7647-22020-01-31C16284748780-19d75b9d0-6406-f424-e053-dadaa90a57ceBenzonatate Capsules, USP 100 mg, 150 mg and 200 mg
63629-7647-32020-01-31C16284748780-19d75b9d0-6406-f424-e053-dadaa90a57ceBenzonatate Capsules, USP 100 mg, 150 mg and 200 mg

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7647-363629764703500 CAPSULE in 1 BOTTLE (63629-7647-3) 500 capsule2018-03-130000-00-00NoNoCurrent