Benzonatate

Product NDC
69452-144
11-digit product format
694520144
Labeler code
69452
Product ID
69452-144_407f50b2-8640-399e-e063-6294a90a4e2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA081297
Marketing category
ANDA
Marketing start
2016-08-15
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
Rxcui197397, 283417

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
69452-144-20Benzonatate100 in 1 BOTTLE, PLASTICCAPSULE1006
69452-144-30Benzonatate500 in 1 BOTTLE, PLASTICCAPSULE5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-144-20EA - Each69452-14415fa785c-0ec3-48dc-b411-ddb9bf860b7812016-12-07
69452-144-30EA - Each69452-14484148c41-e8a4-489e-a42d-b4eb0163241412017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-144BENZONATATE CAPSULE [BIONPHARMA INC.]5Current NDC, Legacy NDC, 2 package rows20241218_2630be01-1d2d-4c40-8e56-8568ea89eacf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSN5728b147-33a0-4534-b936-3e02274d9467102
283417benzonatate 200 MG Oral CapsuleSCD5728b147-33a0-4534-b936-3e02274d9467102
197397benzonatate 100 MG Oral CapsulePSNd580b1c9-d450-4032-acb2-0563c589ed2c8
283417benzonatate 200 MG Oral CapsulePSNd580b1c9-d450-4032-acb2-0563c589ed2c8
197397benzonatate 100 MG Oral CapsuleSCDd580b1c9-d450-4032-acb2-0563c589ed2c8
283417benzonatate 200 MG Oral CapsuleSCDd580b1c9-d450-4032-acb2-0563c589ed2c8
197397benzonatate 100 MG Oral CapsulePSN2630be01-1d2d-4c40-8e56-8568ea89eacf6
283417benzonatate 200 MG Oral CapsulePSN2630be01-1d2d-4c40-8e56-8568ea89eacf6
197397benzonatate 100 MG Oral CapsuleSCD2630be01-1d2d-4c40-8e56-8568ea89eacf6
283417benzonatate 200 MG Oral CapsuleSCD2630be01-1d2d-4c40-8e56-8568ea89eacf6
283417benzonatate 200 MG Oral CapsulePSN63c4ebf2-37b9-4c90-a082-a24c8373a85a5
283417benzonatate 200 MG Oral CapsuleSCD63c4ebf2-37b9-4c90-a082-a24c8373a85a5
283417benzonatate 200 MG Oral CapsulePSNbc435603-ddc4-4083-af09-2e562defbe7f2
283417benzonatate 200 MG Oral CapsuleSCDbc435603-ddc4-4083-af09-2e562defbe7f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69452-144-2069452014420100 CAPSULE in 1 BOTTLE, PLASTIC (69452-144-20) 100 capsule2016-08-150000-00-00NoNoCurrent
69452-144-3069452014430500 CAPSULE in 1 BOTTLE, PLASTIC (69452-144-30) 500 capsule2016-08-150000-00-00NoNoCurrent