BENZONATATE

Product NDC
42708-082
11-digit product format
427080082
Labeler code
42708
Product ID
42708-082_4682a652-1196-5854-e063-6394a90a4c30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BENZONATATE
Dosage form
CAPSULE
Route
ORAL
Labeler
QPharma, Inc.
Application
ANDA040627
Marketing category
ANDA
Marketing start
2017-03-22
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
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
BENZONATATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5P4DHS6ENR
Rxcui283417

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42708-082-21BENZONATATE21 in 1 BOTTLECAPSULE216

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42708-082BENZONATATE CAPSULE [QPHARMA, INC.]5Current NDC, Legacy NDC, 1 package rows20250521_55c4ae18-3e37-4caf-9fdb-9d307970b5f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSN55c4ae18-3e37-4caf-9fdb-9d307970b5f96
283417benzonatate 200 MG Oral CapsuleSCD55c4ae18-3e37-4caf-9fdb-9d307970b5f96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42708-082-214270800822121 CAPSULE in 1 BOTTLE (42708-082-21) 21 capsule2019-02-280000-00-00YesNoCurrent