Benzonatate

Product NDC
60760-869
11-digit product format
607600869
Labeler code
60760
Product ID
60760-869_47e275cc-924c-034f-e063-6294a90a83c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Benzonatate
Listing expiration
2027-12-31

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
60760-869-15Benzonatate15 in 1 BOTTLE, PLASTICCAPSULE153
60760-869-30Benzonatate30 in 1 BOTTLE, PLASTICCAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-869-15EA - Each60760-869a6379856-f354-443b-b934-30ef1f4eba2612026-02-05
60760-869-30EA - Each60760-869df4396d8-9d71-4785-9e39-c591ddf67d1312025-11-13

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60760-869-156076008691515 CAPSULE in 1 BOTTLE, PLASTIC (60760-869-15) 15 capsule2026-01-08NoNoHistorical
60760-869-306076008693030 CAPSULE in 1 BOTTLE, PLASTIC (60760-869-30) 30 capsule2025-09-22NoNoHistorical