Benzonatate

Product NDC
72789-232
11-digit product format
727890232
Labeler code
72789
Product ID
72789-232_2d6c973f-c531-3449-e063-6294a90a3e55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA206948
Marketing category
ANDA
Marketing start
2018-12-21
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
dc429dc2-e942-6686-8d72-b63c57e806aaProduct name520190416
d45c2ed6-126c-dd22-afd2-e29a2ecf77b9Product name320190215

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72789-232-21Benzonatate21 in 1 BOTTLE, PLASTICCAPSULE216
72789-232-30Benzonatate30 in 1 BOTTLE, PLASTICCAPSULE306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-232BENZONATATE CAPSULE [PD-RX PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 2 package rows20250207_7a5460bf-5242-4726-9dfa-e215529842c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSN7a5460bf-5242-4726-9dfa-e215529842c36
283417benzonatate 200 MG Oral CapsuleSCD7a5460bf-5242-4726-9dfa-e215529842c36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-232-217278902322121 CAPSULE in 1 BOTTLE, PLASTIC (72789-232-21) 21 capsule2022-05-090000-00-00NoNoCurrent
72789-232-307278902323030 CAPSULE in 1 BOTTLE, PLASTIC (72789-232-30) 30 capsule2022-02-080000-00-00NoNoCurrent