FDA.reportPublic FDA data

benzonatate

Product NDC
70934-078
11-digit product format
709340078
Labeler code
70934
Product ID
70934-078_b815406b-b482-59af-e053-2995a90a9aa6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA040749
Marketing category
ANDA
Marketing start
2018-02-09
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70934-078IInactivated by FDA2026-07-31
excluded packagepackage70934-07870934-078-20IInactivated by FDA2026-07-31
excluded packagepackage70934-07870934-078-30IInactivated 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
70934-078-202023-01-30C16284748780-1f386c64a-24d6-0266-e053-dadaa90a7c1aBenzonatate Capsules, USP 100 mg, 150 mg and 200 mg
70934-078-302023-01-30C16284748780-1f386c64a-24d6-0266-e053-dadaa90a7c1aBenzonatate Capsules, USP 100 mg, 150 mg and 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-078-20benzonatate20 in 1 BOTTLE, PLASTICCAPSULE203
70934-078-30benzonatate30 in 1 BOTTLE, PLASTICCAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-078-20EA - Each70934-0783e775fc8-0135-4e6a-862e-981df734149912018-05-09
70934-078-30EA - Each70934-078289e7385-c642-454f-abe7-95bbd93d8ca912018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-078BENZONATATE CAPSULE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]3Legacy NDC, 2 package rows20210105_691cee22-9e7a-ffdb-e053-2a91aa0aa08e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSN691cee22-9e7a-ffdb-e053-2a91aa0aa08e3
283417benzonatate 200 MG Oral CapsuleSCD691cee22-9e7a-ffdb-e053-2a91aa0aa08e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-078-207093400782020 CAPSULE in 1 BOTTLE, PLASTIC (70934-078-20) 20 capsule2018-02-090000-00-00NoNoCurrent
70934-078-307093400783030 CAPSULE in 1 BOTTLE, PLASTIC (70934-078-30) 30 capsule2018-02-090000-00-00NoNoCurrent