FDA.reportPublic FDA data

Benzonatate

Product NDC
51655-770
11-digit product format
516550770
Labeler code
51655
Product ID
51655-770_4a29020f-31db-212b-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Northwind Pharmaceuticals, LLC
Application
ANDA040749
Marketing category
ANDA
Marketing start
2014-07-25
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-770-202026-01-08C16284748780-19d75b9cf-d26b-f424-e053-dadaa90a57ce43ef66e1-92c8-48be-8e1e-787a4f9c669a
51655-770-522026-01-08C16284748780-19d75b9cf-d26b-f424-e053-dadaa90a57ce43ef66e1-92c8-48be-8e1e-787a4f9c669a
51655-770-202020-01-31C16284748780-19d75b9cf-d26b-f424-e053-dadaa90a57ce43ef66e1-92c8-48be-8e1e-787a4f9c669a
51655-770-522020-01-31C16284748780-19d75b9cf-d26b-f424-e053-dadaa90a57ce43ef66e1-92c8-48be-8e1e-787a4f9c669a

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZONATATEACTIVE INGREDIENT5P4DHS6ENRBENZONATATE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]2
BENZONATATEACTIVE MOIETY5P4DHS6ENRBENZONATATE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-770BENZONATATE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]3Legacy NDC20170307_43ef66e1-92c8-48be-8e1e-787a4f9c669a.zip