Benzonatate

Product NDC
63629-2476
11-digit product format
636292476
Labeler code
63629
Product ID
63629-2476_6ad351a4-5f72-43d5-bc22-6eea86c0896e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202765
Marketing category
ANDA
Marketing start
2015-08-10
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2476-1Benzonatate100 in 1 BOTTLECAPSULE100104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2476-1EA - Each63629-24767c3fe4a7-d0dc-4e77-af7f-eae899c90a7612021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2476BENZONATATE CAPSULE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20240112_2471d5d9-ea9e-482a-811d-ad173b253be7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSN2471d5d9-ea9e-482a-811d-ad173b253be7104
283417benzonatate 200 MG Oral CapsuleSCD2471d5d9-ea9e-482a-811d-ad173b253be7104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2476-163629247601100 CAPSULE in 1 BOTTLE (63629-2476-1) 100 capsule2015-08-100000-00-00NoNoCurrent