FDA.reportPublic FDA data

Benzonatate

Product NDC
64980-634
11-digit product format
649800634
Labeler code
64980
Product ID
64980-634_4bbf8d39-1a31-43e3-a656-cf98fe991be9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA202765
Marketing category
ANDA
Marketing start
2024-07-26
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
64980-634-01Benzonatate100 in 1 BOTTLECAPSULE1001
64980-634-50Benzonatate500 in 1 BOTTLECAPSULE5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-634-01EA - Each64980-6342c6b4010-3805-4a9c-9e08-240077d65b3412024-12-10
64980-634-50EA - Each64980-6345635c03d-0317-4b5b-a668-4f044a2004d812024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-634BENZONATATE CAPSULE [RISING PHARMA HOLDINGS, INC.]1Current NDC, 2 package rows20240726_0ca22f92-9750-4eb4-8cdb-ebd3b12691cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN3f686042-02bc-8a78-e063-6294a90a7f563
197397benzonatate 100 MG Oral CapsuleSCD3f686042-02bc-8a78-e063-6294a90a7f563
197397benzonatate 100 MG Oral CapsulePSN07018b47-76f5-49d3-b7d3-081f82d382b21
197397benzonatate 100 MG Oral CapsulePSN0ca22f92-9750-4eb4-8cdb-ebd3b12691cc1
197397benzonatate 100 MG Oral CapsulePSN44f2826e-20ff-b53c-e063-6394a90a96301
197397benzonatate 100 MG Oral CapsulePSNe1bf84c8-fc88-4f43-8655-7ce95a4da51f1
283417benzonatate 200 MG Oral CapsulePSN0ca22f92-9750-4eb4-8cdb-ebd3b12691cc1
197397benzonatate 100 MG Oral CapsuleSCD07018b47-76f5-49d3-b7d3-081f82d382b21
197397benzonatate 100 MG Oral CapsuleSCD0ca22f92-9750-4eb4-8cdb-ebd3b12691cc1
197397benzonatate 100 MG Oral CapsuleSCD44f2826e-20ff-b53c-e063-6394a90a96301
197397benzonatate 100 MG Oral CapsuleSCDe1bf84c8-fc88-4f43-8655-7ce95a4da51f1
283417benzonatate 200 MG Oral CapsuleSCD0ca22f92-9750-4eb4-8cdb-ebd3b12691cc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64980-634-0164980063401100 CAPSULE in 1 BOTTLE (64980-634-01) 100 capsule2024-07-26NoNoCurrent
64980-634-5064980063450500 CAPSULE in 1 BOTTLE (64980-634-50) 500 capsule2024-07-26NoNoCurrent