FDA.reportPublic FDA data

benzonatate

Product NDC
55700-561
Requested package NDC
55700-561-30
11-digit product format
557000561
Labeler code
55700
Product ID
55700-561_2901aa20-7fe4-4488-ac08-0acc63d8efaf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA040749
Marketing category
ANDA
Marketing start
2017-11-17
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
2020-12-31
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 packagepackage55700-56155700-561-30DDiscontinued by firm2026-07-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-561-202025-01-09C16284748780-1f386c64a-27fe-0266-e053-dadaa90a7c1aBenzonatate Capsules, USP 100 mg, 150 mg and 200 mg
55700-561-302025-01-09C16284748780-1f386c64a-27fe-0266-e053-dadaa90a7c1aBenzonatate Capsules, USP 100 mg, 150 mg and 200 mg
55700-561-202023-01-30C16284748780-1f386c64a-27fe-0266-e053-dadaa90a7c1aBenzonatate Capsules, USP 100 mg, 150 mg and 200 mg
55700-561-302023-01-30C16284748780-1f386c64a-27fe-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
55700-561-20EA - Each55700-561bd634a20-68d7-4c0b-b72a-79f9e80a284512017-12-14
55700-561-30EA - Each55700-5615b384e6e-92a7-435e-aeb4-083a633f9d5912017-12-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-561-305570005613030 CAPSULE in 1 BOTTLE (55700-561-30) 30 capsule2017-11-170000-00-00NoNoCurrent