Benzonatate

Product NDC
69452-143
11-digit product format
694520143
Labeler code
69452
Product ID
69452-143_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
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, 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
69452-143-20Benzonatate100 in 1 BOTTLE, PLASTICCAPSULE1006
69452-143-30Benzonatate500 in 1 BOTTLE, PLASTICCAPSULE5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-143-20EA - Each69452-143bcbf3bb5-c685-429d-9156-2e5426e3949f12017-07-07
69452-143-30EA - Each69452-143ecbc2d8b-2d50-48bb-9583-7f6a9245f0de12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-143BENZONATATE 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
197397benzonatate 100 MG Oral CapsulePSN540d2bc6-11dc-43d7-b616-b89d75b81cd1104
197397benzonatate 100 MG Oral CapsuleSCD540d2bc6-11dc-43d7-b616-b89d75b81cd1104
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 CapsulePSN686b0e88-7a09-966b-e053-2991aa0ac9c46
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
197397benzonatate 100 MG Oral CapsuleSCD686b0e88-7a09-966b-e053-2991aa0ac9c46
283417benzonatate 200 MG Oral CapsuleSCD2630be01-1d2d-4c40-8e56-8568ea89eacf6
197397benzonatate 100 MG Oral CapsulePSN0d14cbf4-f43f-4ad2-8e8b-7a844e4177024
197397benzonatate 100 MG Oral CapsulePSN49fce8e7-5567-4b55-b3ae-add41f7fefac4
197397benzonatate 100 MG Oral CapsuleSCD49fce8e7-5567-4b55-b3ae-add41f7fefac4
197397benzonatate 100 MG Oral CapsuleSCD0d14cbf4-f43f-4ad2-8e8b-7a844e4177024
197397benzonatate 100 MG Oral CapsulePSN96b260c3-e177-73c3-e053-2a95a90a775e3
197397benzonatate 100 MG Oral CapsulePSN9cab4544-e0ab-3fdd-e053-2995a90ad0493
197397benzonatate 100 MG Oral CapsuleSCD96b260c3-e177-73c3-e053-2a95a90a775e3
197397benzonatate 100 MG Oral CapsuleSCD9cab4544-e0ab-3fdd-e053-2995a90ad0493
197397benzonatate 100 MG Oral CapsulePSN2ce035ff-42cb-d8ef-e063-6294a90a0c061
197397benzonatate 100 MG Oral CapsuleSCD2ce035ff-42cb-d8ef-e063-6294a90a0c061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69452-143-2069452014320100 CAPSULE in 1 BOTTLE, PLASTIC (69452-143-20) 100 capsule2016-08-150000-00-00NoNoCurrent
69452-143-3069452014330500 CAPSULE in 1 BOTTLE, PLASTIC (69452-143-30) 500 capsule2016-08-150000-00-00NoNoCurrent