FDA.reportPublic FDA data

Benzonatate

Product NDC
67296-1751
11-digit product format
672961751
Labeler code
67296
Product ID
67296-1751_3252d7f4-3dc9-819c-e063-6294a90a9fa1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA206948
Marketing category
ANDA
Marketing start
2020-01-01
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1751-32024-08-02C16284748780-11030e365-37fc-111a-e063-dadaa90a10e2Benzonatate 200mg
67296-1751-32024-01-30C16284748780-11030e365-37fc-111a-e063-dadaa90a10e2Benzonatate 200mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1751-3Benzonatate30 in 1 BOTTLECAPSULE304
67296-1751-5Benzonatate15 in 1 BOTTLECAPSULE154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1751BENZONATATE CAPSULE [REDPHARM DRUG, INC.]4Current NDC, Legacy NDC, 2 package rows20250410_a2f6acff-70ff-79f1-e053-2a95a90a6005.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSNa2f6acff-70ff-79f1-e053-2a95a90a60054
283417benzonatate 200 MG Oral CapsuleSCDa2f6acff-70ff-79f1-e053-2a95a90a60054

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1751-36729617510330 CAPSULE in 1 BOTTLE (67296-1751-3) 30 capsule2020-01-010000-00-00NoNoCurrent
67296-1751-56729617510515 CAPSULE in 1 BOTTLE (67296-1751-5) 15 capsule2020-01-01NoNoCurrent