FDA.reportPublic FDA data

Benzonatate

Product NDC
85766-089
11-digit product format
857660089
Labeler code
85766
Product ID
85766-089_4ed84766-51d2-3f2e-e063-6294a90a4109
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Sportpharm LLC
Application
ANDA206948
Marketing category
ANDA
Marketing start
2018-12-21
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, 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
85766-089-01Benzonatate100 in 1 BOTTLECAPSULE1001
85766-089-05Benzonatate500 in 1 BOTTLECAPSULE5001
85766-089-10Benzonatate10 in 1 BOTTLECAPSULE101
85766-089-20Benzonatate20 in 1 BOTTLECAPSULE201
85766-089-21Benzonatate21 in 1 BOTTLECAPSULE211
85766-089-30Benzonatate30 in 1 BOTTLECAPSULE301
85766-089-60Benzonatate60 in 1 BOTTLECAPSULE601
85766-089-90Benzonatate90 in 1 BOTTLECAPSULE901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN0e8f2562-2449-430f-85bb-f9195644cdfa1
283417benzonatate 200 MG Oral CapsulePSN0e8f2562-2449-430f-85bb-f9195644cdfa1
197397benzonatate 100 MG Oral CapsuleSCD0e8f2562-2449-430f-85bb-f9195644cdfa1
283417benzonatate 200 MG Oral CapsuleSCD0e8f2562-2449-430f-85bb-f9195644cdfa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-089-0185766008901100 CAPSULE in 1 BOTTLE (85766-089-01) 100 capsule2026-04-07NoNoHistorical
85766-089-0585766008905500 CAPSULE in 1 BOTTLE (85766-089-05) 500 capsule2026-04-07NoNoHistorical
85766-089-108576600891010 CAPSULE in 1 BOTTLE (85766-089-10) 10 capsule2026-04-07NoNoHistorical
85766-089-208576600892020 CAPSULE in 1 BOTTLE (85766-089-20) 20 capsule2026-04-07NoNoHistorical
85766-089-218576600892121 CAPSULE in 1 BOTTLE (85766-089-21) 21 capsule2026-04-07NoNoHistorical
85766-089-308576600893030 CAPSULE in 1 BOTTLE (85766-089-30) 30 capsule2026-04-07NoNoHistorical
85766-089-608576600896060 CAPSULE in 1 BOTTLE (85766-089-60) 60 capsule2026-04-07NoNoHistorical
85766-089-908576600899090 CAPSULE in 1 BOTTLE (85766-089-90) 90 capsule2026-04-07NoNoHistorical