FDA.reportPublic FDA data

Benzonatate

Product NDC
68788-8405
11-digit product format
687888405
Labeler code
68788
Product ID
68788-8405_1f2c1b46-90b1-4d9a-b5a7-77aeb01ce292
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA040597
Marketing category
ANDA
Marketing start
2023-03-29
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
68788-8405-1Benzonatate15 in 1 BOTTLECAPSULE154
68788-8405-2Benzonatate20 in 1 BOTTLECAPSULE204
68788-8405-3Benzonatate30 in 1 BOTTLECAPSULE304
68788-8405-6Benzonatate60 in 1 BOTTLECAPSULE604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8405-1EA - Each68788-8405eb4a74c9-2c53-4543-8dc2-08af1763438712023-06-06
68788-8405-2EA - Each68788-8405d35a9a54-0366-48c4-af97-7513ce28c6a812023-06-06
68788-8405-3EA - Each68788-84053e386727-88db-427a-893b-b0ac0ef7335f12023-06-06
68788-8405-6EA - Each68788-8405c0154b92-cf09-444b-9056-0c97555d4a9f12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8405BENZONATATE CAPSULE [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 4 package rows20250209_6f7f4a31-99ec-45ca-84d7-0be3640d1e0b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSN6f7f4a31-99ec-45ca-84d7-0be3640d1e0b4
283417benzonatate 200 MG Oral CapsuleSCD6f7f4a31-99ec-45ca-84d7-0be3640d1e0b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8405-16878884050115 CAPSULE in 1 BOTTLE (68788-8405-1) 15 capsule2023-03-29NoNoHistorical
68788-8405-26878884050220 CAPSULE in 1 BOTTLE (68788-8405-2) 20 capsule2023-03-29NoNoHistorical
68788-8405-36878884050330 CAPSULE in 1 BOTTLE (68788-8405-3) 30 capsule2023-03-29NoNoHistorical
68788-8405-66878884050660 CAPSULE in 1 BOTTLE (68788-8405-6) 60 capsule2023-03-29NoNoHistorical