FDA.reportPublic FDA data

Benzonatate

Product NDC
76420-804
11-digit product format
764200804
Labeler code
76420
Product ID
76420-804_3306a754-a59a-d003-e063-6294a90a65c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, 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
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
76420-804-01Benzonatate100 in 1 BOTTLECAPSULE1002
76420-804-05Benzonatate500 in 1 BOTTLECAPSULE5002
76420-804-20Benzonatate20 in 1 BOTTLECAPSULE202
76420-804-30Benzonatate30 in 1 BOTTLECAPSULE302
76420-804-60Benzonatate60 in 1 BOTTLECAPSULE602
76420-804-90Benzonatate90 in 1 BOTTLECAPSULE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-804BENZONATATE CAPSULE [ASCLEMED USA, INC.]2Current NDC, 6 package rows20250419_25ed5206-b322-486f-9e54-14125f6e74c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN25ed5206-b322-486f-9e54-14125f6e74c52
283417benzonatate 200 MG Oral CapsulePSN25ed5206-b322-486f-9e54-14125f6e74c52
197397benzonatate 100 MG Oral CapsuleSCD25ed5206-b322-486f-9e54-14125f6e74c52
283417benzonatate 200 MG Oral CapsuleSCD25ed5206-b322-486f-9e54-14125f6e74c52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-804-0176420080401100 CAPSULE in 1 BOTTLE (76420-804-01) 100 capsule2024-04-29NoNoHistorical
76420-804-0576420080405500 CAPSULE in 1 BOTTLE (76420-804-05) 500 capsule2024-04-29NoNoHistorical
76420-804-207642008042020 CAPSULE in 1 BOTTLE (76420-804-20) 20 capsule2025-04-18NoNoHistorical
76420-804-307642008043030 CAPSULE in 1 BOTTLE (76420-804-30) 30 capsule2024-04-29NoNoHistorical
76420-804-607642008046060 CAPSULE in 1 BOTTLE (76420-804-60) 60 capsule2024-04-29NoNoHistorical
76420-804-907642008049090 CAPSULE in 1 BOTTLE (76420-804-90) 90 capsule2024-04-29NoNoHistorical