Benzonatate

Product NDC
50090-5986
11-digit product format
500905986
Labeler code
50090
Product ID
50090-5986_6a48ed2b-8479-4e06-8048-e48453bf80d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA206948
Marketing category
ANDA
Marketing start
2018-12-21
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
50090-5986-0Benzonatate15 in 1 BOTTLECAPSULE153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5986BENZONATATE CAPSULE [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 1 package rows20231125_434130e1-c29c-4029-92c6-7d0f7a928e68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN434130e1-c29c-4029-92c6-7d0f7a928e683
197397benzonatate 100 MG Oral CapsuleSCD434130e1-c29c-4029-92c6-7d0f7a928e683

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5986-05009059860015 CAPSULE in 1 BOTTLE (50090-5986-0) 15 capsule2022-05-310000-00-00NoNoCurrent