Benzonatate

Product NDC
23155-899
11-digit product format
231550899
Labeler code
23155
Product ID
23155-899_0421e0c9-c73e-4eb4-a0cf-c67241a4749e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA040682
Marketing category
ANDA
Marketing start
2024-09-29
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
dc429dc2-e942-6686-8d72-b63c57e806aaProduct name520190416
d45c2ed6-126c-dd22-afd2-e29a2ecf77b9Product name320190215

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-899-01Benzonatate100 in 1 BOTTLECAPSULE, LIQUID FILLED1001
23155-899-05Benzonatate500 in 1 BOTTLECAPSULE, LIQUID FILLED5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-899-01EA - Each23155-899dd7ebc9a-5a40-4e5d-8259-d4b63ab3dc1712025-02-10
23155-899-05EA - Each23155-8991eca2551-0b4d-48c1-b75d-c6e3deb76b0512025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-899BENZONATATE CAPSULE, LIQUID FILLED [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]1Current NDC, 2 package rows20240929_f32014c7-bc0c-4edb-b591-7baa6664d74b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSNf32014c7-bc0c-4edb-b591-7baa6664d74b1
283417benzonatate 200 MG Oral CapsulePSN46e97547-23d9-114a-e063-6394a90a920b1
283417benzonatate 200 MG Oral CapsulePSNf32014c7-bc0c-4edb-b591-7baa6664d74b1
197397benzonatate 100 MG Oral CapsuleSCDf32014c7-bc0c-4edb-b591-7baa6664d74b1
283417benzonatate 200 MG Oral CapsuleSCD46e97547-23d9-114a-e063-6394a90a920b1
283417benzonatate 200 MG Oral CapsuleSCDf32014c7-bc0c-4edb-b591-7baa6664d74b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
23155-899-0123155089901100 CAPSULE, LIQUID FILLED in 1 BOTTLE (23155-899-01) 2024-09-29NoNoCurrent
23155-899-0523155089905500 CAPSULE, LIQUID FILLED in 1 BOTTLE (23155-899-05) 2024-09-29NoNoCurrent