Benzonatate

Product NDC
60760-700
11-digit product format
607600700
Labeler code
60760
Product ID
60760-700_07efb1df-d506-dfe4-e063-6294a90a214b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA206948
Marketing category
ANDA
Marketing start
2019-10-25
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
60760-700-15Benzonatate15 in 1 BOTTLE, PLASTICCAPSULE152
60760-700-30Benzonatate30 in 1 BOTTLE, PLASTICCAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-700BENZONATATE CAPSULE [ST. MARY'S MEDICAL PARK PHARMACY]2Current NDC, Legacy NDC, 2 package rows20231025_96250e05-4608-7d5c-e053-2995a90ad57a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN96250e05-4608-7d5c-e053-2995a90ad57a2
197397benzonatate 100 MG Oral CapsuleSCD96250e05-4608-7d5c-e053-2995a90ad57a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60760-700-156076007001515 CAPSULE in 1 BOTTLE, PLASTIC (60760-700-15) 15 capsule2023-10-17NoNoCurrent
60760-700-306076007003030 CAPSULE in 1 BOTTLE, PLASTIC (60760-700-30) 30 capsule2019-10-250000-00-00NoNoCurrent