FDA.reportPublic FDA data

Benzonatate

Product NDC
68788-7607
11-digit product format
687887607
Labeler code
68788
Product ID
68788-7607_33ce4923-a290-4c25-95f2-67f8b25fd3e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc
Application
ANDA206948
Marketing category
ANDA
Marketing start
2020-02-07
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

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
68788-7607-0Benzonatate9 in 1 BOTTLECAPSULE98
68788-7607-1Benzonatate100 in 1 BOTTLECAPSULE1008
68788-7607-2Benzonatate20 in 1 BOTTLECAPSULE208
68788-7607-3Benzonatate30 in 1 BOTTLECAPSULE308
68788-7607-4Benzonatate40 in 1 BOTTLECAPSULE408
68788-7607-5Benzonatate15 in 1 BOTTLECAPSULE158
68788-7607-9Benzonatate90 in 1 BOTTLECAPSULE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7607-0EA - Each68788-7607d478b4b4-7df9-4996-adaa-aa598f87238812020-03-10
68788-7607-1EA - Each68788-76071cb5af3a-f12e-4225-8921-bcb6bb896c9912020-03-10
68788-7607-2EA - Each68788-76073b14dfc5-657b-4093-ab9c-b96c4bb2645f12020-03-10
68788-7607-3EA - Each68788-7607561c44a3-e4d7-4301-8421-c92158bc298c12020-03-10
68788-7607-4EA - Each68788-76071ceb869b-e4f4-49ea-ae23-1b0c93882f9c12020-03-10
68788-7607-5EA - Each68788-76075316d7c4-4da7-45f1-81a8-b7e3a9febbcf12020-03-10
68788-7607-9EA - Each68788-760786f28dc3-3778-4894-9400-d1a98ece86bb12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7607BENZONATATE CAPSULE [PREFERRED PHARMACEUTICALS INC]7Current NDC, Legacy NDC, 7 package rows20250207_3309040d-e240-42f6-9c51-5c54604a3896.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN3309040d-e240-42f6-9c51-5c54604a38968
197397benzonatate 100 MG Oral CapsuleSCD3309040d-e240-42f6-9c51-5c54604a38968

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7607-0687887607009 CAPSULE in 1 BOTTLE (68788-7607-0) 9 capsule2020-02-070000-00-00NoNoCurrent
68788-7607-168788760701100 CAPSULE in 1 BOTTLE (68788-7607-1) 100 capsule2020-02-070000-00-00NoNoCurrent
68788-7607-26878876070220 CAPSULE in 1 BOTTLE (68788-7607-2) 20 capsule2020-02-070000-00-00NoNoCurrent
68788-7607-36878876070330 CAPSULE in 1 BOTTLE (68788-7607-3) 30 capsule2020-02-070000-00-00NoNoCurrent
68788-7607-46878876070440 CAPSULE in 1 BOTTLE (68788-7607-4) 40 capsule2020-02-070000-00-00NoNoCurrent
68788-7607-56878876070515 CAPSULE in 1 BOTTLE (68788-7607-5) 15 capsule2020-02-070000-00-00NoNoCurrent
68788-7607-96878876070990 CAPSULE in 1 BOTTLE (68788-7607-9) 90 capsule2020-02-070000-00-00NoNoCurrent