FDA.reportPublic FDA data

BENZONATATE

Product NDC
61919-517
Requested package NDC
61919-517-20
11-digit product format
619190517
Labeler code
61919
Product ID
61919-517_ea4e7175-945e-6be8-e053-2a95a90a507c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BENZONATATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA040749
Marketing category
ANDA
Marketing start
2019-07-30
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
2023-12-31
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 packagepackage61919-51761919-517-20DDiscontinued 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

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
61919-517-302024-01-30C16284748780-11030e365-66f7-111a-e063-dadaa90a10e2BENZONATATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-517-30BENZONATATE30 in 1 BOTTLECAPSULE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-517-20EA - Each61919-517cdc553d8-856f-4257-bbd4-026578a6377a12019-08-06
61919-517-30EA - Each61919-517c54723f9-0cc7-4e6e-8eca-71c49a6cc5bb12019-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZONATATEACTIVE INGREDIENT5P4DHS6ENRBENZONATATE CAPSULE [DIRECT RX]3
BENZONATATEACTIVE MOIETY5P4DHS6ENRBENZONATATE CAPSULE [DIRECT RX]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MBENZONATATE CAPSULE [DIRECT RX]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XBENZONATATE CAPSULE [DIRECT RX]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBENZONATATE CAPSULE [DIRECT RX]3
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OBENZONATATE CAPSULE [DIRECT RX]3
GELATININACTIVE INGREDIENT2G86QN327LBENZONATATE CAPSULE [DIRECT RX]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBENZONATATE CAPSULE [DIRECT RX]3
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UBENZONATATE CAPSULE [DIRECT RX]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BENZONATATE CAPSULE [DIRECT RX]3
SHELLACINACTIVE INGREDIENT46N107B71OBENZONATATE CAPSULE [DIRECT RX]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENZONATATE CAPSULE [DIRECT RX]3
WATERINACTIVE INGREDIENT059QF0KO0RBENZONATATE CAPSULE [DIRECT RX]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-517BENZONATATE CAPSULE [DIRECT RX]5Legacy NDC, 1 package rows20190404_2c3483d2-488d-41d9-9bfb-49e7dc64e307.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSN2c3483d2-488d-41d9-9bfb-49e7dc64e3075
283417benzonatate 200 MG Oral CapsuleSCD2c3483d2-488d-41d9-9bfb-49e7dc64e3075

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-517-206191905172020 CAPSULE in 1 BOTTLE (61919-517-20) 20 capsule2019-07-300000-00-00NoNoCurrent