FDA.reportPublic FDA data

Benzonatate

Product NDC
68788-8329
11-digit product format
687888329
Labeler code
68788
Product ID
68788-8329_8107f64d-3336-46e7-b06c-e10c39d8beb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA206948
Marketing category
ANDA
Marketing start
2023-01-20
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
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
68788-8329-1Benzonatate15 in 1 BOTTLECAPSULE154
68788-8329-2Benzonatate20 in 1 BOTTLECAPSULE204
68788-8329-3Benzonatate30 in 1 BOTTLECAPSULE304
68788-8329-6Benzonatate60 in 1 BOTTLECAPSULE604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8329-1EA - Each68788-8329f83acc8d-605d-4e0c-bc97-c0ebd8e2a24412023-02-06
68788-8329-2EA - Each68788-832978351acd-a396-46c4-ac49-137f58fd600612023-02-06
68788-8329-3EA - Each68788-8329179d0d56-7067-4fdc-8f5e-7792a55b6f2612023-02-06
68788-8329-6EA - Each68788-8329e3a5bf6d-b858-422d-8427-6b6f1066c26212023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8329BENZONATATE CAPSULE [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 4 package rows20250209_f2cd05a6-2b8b-4731-b97b-b6677fbabbcf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSNf2cd05a6-2b8b-4731-b97b-b6677fbabbcf4
283417benzonatate 200 MG Oral CapsuleSCDf2cd05a6-2b8b-4731-b97b-b6677fbabbcf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8329-16878883290115 CAPSULE in 1 BOTTLE (68788-8329-1) 15 capsule2023-01-20NoNoHistorical
68788-8329-26878883290220 CAPSULE in 1 BOTTLE (68788-8329-2) 20 capsule2023-01-20NoNoHistorical
68788-8329-36878883290330 CAPSULE in 1 BOTTLE (68788-8329-3) 30 capsule2023-01-20NoNoHistorical
68788-8329-66878883290660 CAPSULE in 1 BOTTLE (68788-8329-6) 60 capsule2023-01-20NoNoHistorical