FDA.reportPublic FDA data

Benzonatate

Product NDC
71610-692
11-digit product format
716100692
Labeler code
71610
Product ID
71610-692_48b92534-e189-4b18-906f-8a4abcb776a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA081297
Marketing category
ANDA
Marketing start
2017-01-18
Substance
BENZONATATE
Active strength
100 mg/1
Pharmacologic classes
Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Benzonatate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZONATATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5P4DHS6ENR
Rxcui197397

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc429dc2-e942-6686-8d72-b63c57e806aaProduct name520190416
d45c2ed6-126c-dd22-afd2-e29a2ecf77b9Product name320190215

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-692-30Benzonatate30 in 1 BOTTLE, PLASTICCAPSULE302
71610-692-53Benzonatate60 in 1 BOTTLE, PLASTICCAPSULE602
71610-692-60Benzonatate90 in 1 BOTTLE, PLASTICCAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-692-30EA - Each71610-69293bd5e97-6cc2-44cd-b426-2d521784234312024-01-04
71610-692-53EA - Each71610-692c366f86a-926c-4ab5-ba8b-ab4889a53ab012024-01-04
71610-692-60EA - Each71610-692c7dcaa92-4a8b-4841-be60-dfb879eea8f412024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-692BENZONATATE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, 3 package rows20230316_3bd33aec-9a30-4581-bd28-6cfb67772cef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN3bd33aec-9a30-4581-bd28-6cfb67772cef2
197397benzonatate 100 MG Oral CapsuleSCD3bd33aec-9a30-4581-bd28-6cfb67772cef2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-692-307161006923030 CAPSULE in 1 BOTTLE, PLASTIC (71610-692-30) 30 capsule2023-03-10NoNoHistorical
71610-692-537161006925360 CAPSULE in 1 BOTTLE, PLASTIC (71610-692-53) 60 capsule2023-03-10NoNoHistorical
71610-692-607161006926090 CAPSULE in 1 BOTTLE, PLASTIC (71610-692-60) 90 capsule2023-03-10NoNoHistorical