FDA.reportPublic FDA data

Benzonatate

Product NDC
85766-068
11-digit product format
857660068
Labeler code
85766
Product ID
85766-068_502f32fd-33c9-391e-e063-6394a90a30b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Sportpharm LLC
Application
ANDA211518
Marketing category
ANDA
Marketing start
2019-02-22
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
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
BENZONATATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5P4DHS6ENR
Rxcui197397, 283417, 903291

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
85766-068-01Benzonatate100 in 1 BOTTLECAPSULE1002
85766-068-05Benzonatate500 in 1 BOTTLECAPSULE5002
85766-068-15Benzonatate15 in 1 BOTTLECAPSULE152
85766-068-20Benzonatate20 in 1 BOTTLECAPSULE202
85766-068-21Benzonatate21 in 1 BOTTLECAPSULE212
85766-068-30Benzonatate30 in 1 BOTTLECAPSULE302
85766-068-60Benzonatate60 in 1 BOTTLECAPSULE602
85766-068-90Benzonatate90 in 1 BOTTLECAPSULE902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSNdf48d617-a3c2-4776-937d-ccfca651d4fc2
903291benzonatate 150 MG Oral CapsulePSNdf48d617-a3c2-4776-937d-ccfca651d4fc2
283417benzonatate 200 MG Oral CapsulePSNdf48d617-a3c2-4776-937d-ccfca651d4fc2
197397benzonatate 100 MG Oral CapsuleSCDdf48d617-a3c2-4776-937d-ccfca651d4fc2
903291benzonatate 150 MG Oral CapsuleSCDdf48d617-a3c2-4776-937d-ccfca651d4fc2
283417benzonatate 200 MG Oral CapsuleSCDdf48d617-a3c2-4776-937d-ccfca651d4fc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-068-0185766006801100 CAPSULE in 1 BOTTLE (85766-068-01) 100 capsule2025-10-14NoNoHistorical
85766-068-0585766006805500 CAPSULE in 1 BOTTLE (85766-068-05) 500 capsule2025-10-14NoNoHistorical
85766-068-158576600681515 CAPSULE in 1 BOTTLE (85766-068-15) 15 capsule2025-10-14NoNoHistorical
85766-068-208576600682020 CAPSULE in 1 BOTTLE (85766-068-20) 20 capsule2025-10-14NoNoHistorical
85766-068-218576600682121 CAPSULE in 1 BOTTLE (85766-068-21) 21 capsule2025-10-14NoNoHistorical
85766-068-308576600683030 CAPSULE in 1 BOTTLE (85766-068-30) 30 capsule2025-10-14NoNoHistorical
85766-068-608576600686060 CAPSULE in 1 BOTTLE (85766-068-60) 60 capsule2025-10-14NoNoHistorical
85766-068-908576600689090 CAPSULE in 1 BOTTLE (85766-068-90) 90 capsule2025-10-14NoNoHistorical