FDA.reportPublic FDA data

BENZONATATE

Product NDC
51655-772
11-digit product format
516550772
Labeler code
51655
Product ID
51655-772_ec9bda2c-edcd-4f80-bfd7-8b543bd51af3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BENZONATATE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Northwind Pharmaceuticals, LLC
Application
ANDA040682
Marketing category
ANDA
Marketing start
2015-03-12
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-772-522026-01-08C16284748780-19d75b9d0-86e3-f424-e053-dadaa90a57ceaea9ac9f-56ac-4ab2-a65e-17e859672c6e
51655-772-852026-01-08C16284748780-19d75b9d0-86e3-f424-e053-dadaa90a57ceaea9ac9f-56ac-4ab2-a65e-17e859672c6e
51655-772-522020-01-31C16284748780-19d75b9d0-86e3-f424-e053-dadaa90a57ceaea9ac9f-56ac-4ab2-a65e-17e859672c6e
51655-772-852020-01-31C16284748780-19d75b9d0-86e3-f424-e053-dadaa90a57ceaea9ac9f-56ac-4ab2-a65e-17e859672c6e

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-772BENZONATATE CAPSULE, LIQUID FILLED [NORTHWIND PHARMACEUTICALS, LLC]2Legacy NDC20150407_aea9ac9f-56ac-4ab2-a65e-17e859672c6e.zip