Benzonatate

Product NDC
63629-1229
11-digit product format
636291229
Labeler code
63629
Product ID
63629-1229_28735db3-6d86-4414-910f-987f53e3fbcc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211518
Marketing category
ANDA
Marketing start
2019-02-22
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
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
63629-1229-1Benzonatate100 in 1 BOTTLECAPSULE100104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1229-1EA - Each63629-122932b21762-368a-43bb-a2ec-98fc231806b512021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1229BENZONATATE CAPSULE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20230520_0f91fd98-1a86-42aa-8055-d339bff73015.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSN0f91fd98-1a86-42aa-8055-d339bff73015104
283417benzonatate 200 MG Oral CapsuleSCD0f91fd98-1a86-42aa-8055-d339bff73015104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1229-163629122901100 CAPSULE in 1 BOTTLE (63629-1229-1) 100 capsule2019-02-220000-00-00NoNoCurrent