Benzonatate

Product NDC
63629-2473
11-digit product format
636292473
Labeler code
63629
Product ID
63629-2473_1a9d043d-4d3f-442d-909a-5f1312d3fbcd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202765
Marketing category
ANDA
Marketing start
2017-09-07
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

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
63629-2473-1Benzonatate500 in 1 BOTTLECAPSULE500108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2473-1EA - Each63629-247364cfa5f8-dfdc-4e82-93df-3f760ee736e112021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2473BENZONATATE CAPSULE [BRYANT RANCH PREPACK]108Current NDC, Legacy NDC, 1 package rows20240821_5008eb9e-b209-4393-8d13-bb92976e8dde.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN5008eb9e-b209-4393-8d13-bb92976e8dde108
197397benzonatate 100 MG Oral CapsuleSCD5008eb9e-b209-4393-8d13-bb92976e8dde108

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2473-163629247301500 CAPSULE in 1 BOTTLE (63629-2473-1) 500 capsule2017-09-070000-00-00NoNoCurrent