Benzonatate

Product NDC
50090-4968
11-digit product format
500904968
Labeler code
50090
Product ID
50090-4968_307aec37-9f24-4b15-84e0-c679d4d26643
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202765
Marketing category
ANDA
Marketing start
2017-09-07
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4968-02023-02-07C16284748780-1f386c649-9dca-0266-e053-dadaa90a7c1aBenzonatate Capsules USP, 100 mg and 200 mg
50090-4968-02023-01-30C16284748780-1f386c649-9dca-0266-e053-dadaa90a7c1aBenzonatate Capsules USP, 100 mg and 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4968-0Benzonatate15 in 1 BOTTLECAPSULE156

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4968BENZONATATE CAPSULE [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 1 package rows20231112_36c3f916-cc4e-4e09-8419-4d6b64157e32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN36c3f916-cc4e-4e09-8419-4d6b64157e326
197397benzonatate 100 MG Oral CapsuleSCD36c3f916-cc4e-4e09-8419-4d6b64157e326

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4968-05009049680015 CAPSULE in 1 BOTTLE (50090-4968-0) 15 capsule2021-09-170000-00-00NoNoCurrent