FDA.reportPublic FDA data

Benzonatate

Product NDC
68788-8336
11-digit product format
687888336
Labeler code
68788
Product ID
68788-8336_cb8266bf-7543-4ac4-aaea-086a497079f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA211518
Marketing category
ANDA
Marketing start
2023-04-06
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
68788-8336-1Benzonatate15 in 1 BOTTLECAPSULE154
68788-8336-2Benzonatate20 in 1 BOTTLECAPSULE204
68788-8336-3Benzonatate30 in 1 BOTTLECAPSULE304
68788-8336-6Benzonatate60 in 1 BOTTLECAPSULE604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8336-1EA - Each68788-833607fc3e5a-6b8a-4cc7-94d9-19b03cbb279912023-04-07
68788-8336-2EA - Each68788-833695e541f3-d31a-4f8c-b87f-3a34d5758be612023-04-07
68788-8336-3EA - Each68788-8336990ed44c-63e7-433a-8534-61ebbabf69c812023-04-07
68788-8336-6EA - Each68788-8336422fb261-3701-46d0-9605-1ba61f08decb12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8336BENZONATATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3Current NDC, 4 package rows20250209_fe5e8a94-ac75-4657-a45a-1fe94dbe0d43.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSNfe5e8a94-ac75-4657-a45a-1fe94dbe0d434
283417benzonatate 200 MG Oral CapsuleSCDfe5e8a94-ac75-4657-a45a-1fe94dbe0d434

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8336-16878883360115 CAPSULE in 1 BOTTLE (68788-8336-1) 15 capsule2023-04-06NoNoHistorical
68788-8336-26878883360220 CAPSULE in 1 BOTTLE (68788-8336-2) 20 capsule2023-04-06NoNoHistorical
68788-8336-36878883360330 CAPSULE in 1 BOTTLE (68788-8336-3) 30 capsule2023-04-06NoNoHistorical
68788-8336-66878883360660 CAPSULE in 1 BOTTLE (68788-8336-6) 60 capsule2023-04-06NoNoHistorical