FDA.reportPublic FDA data

Benzonatate

Product NDC
64980-635
11-digit product format
649800635
Labeler code
64980
Product ID
64980-635_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
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
dc429dc2-e942-6686-8d72-b63c57e806aaProduct name520190416
d45c2ed6-126c-dd22-afd2-e29a2ecf77b9Product name320190215

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64980-635-01Benzonatate100 in 1 BOTTLECAPSULE1001
64980-635-50Benzonatate500 in 1 BOTTLECAPSULE5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-635-01EA - Each64980-635e0cf5e37-f461-4447-adb7-064ebcf7e5e912024-12-10
64980-635-50EA - Each64980-6350c6f2073-1187-4e8a-9426-37d070559aa012024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-635BENZONATATE 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
283417benzonatate 200 MG Oral CapsulePSN284a8cbb-632b-41ba-97b8-07fe70c14a832
283417benzonatate 200 MG Oral CapsuleSCD284a8cbb-632b-41ba-97b8-07fe70c14a832
197397benzonatate 100 MG Oral CapsulePSN0ca22f92-9750-4eb4-8cdb-ebd3b12691cc1
283417benzonatate 200 MG Oral CapsulePSN0ca22f92-9750-4eb4-8cdb-ebd3b12691cc1
283417benzonatate 200 MG Oral CapsulePSN52c5cb10-0877-e27f-e063-6394a90a4a2d1
197397benzonatate 100 MG Oral CapsuleSCD0ca22f92-9750-4eb4-8cdb-ebd3b12691cc1
283417benzonatate 200 MG Oral CapsuleSCD0ca22f92-9750-4eb4-8cdb-ebd3b12691cc1
283417benzonatate 200 MG Oral CapsuleSCD52c5cb10-0877-e27f-e063-6394a90a4a2d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64980-635-0164980063501100 CAPSULE in 1 BOTTLE (64980-635-01) 100 capsule2024-07-26NoNoCurrent
64980-635-5064980063550500 CAPSULE in 1 BOTTLE (64980-635-50) 500 capsule2024-07-26NoNoCurrent