benzonatate

Product NDC
67296-0581
11-digit product format
672960581
Labeler code
67296
Product ID
67296-0581_c69fc778-67bf-40cf-b91a-f5e1e98e5875
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug Inc.
Application
ANDA040627
Marketing category
ANDA
Marketing start
2007-07-25
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
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc429dc2-e942-6686-8d72-b63c57e806aaProduct name520190416
d45c2ed6-126c-dd22-afd2-e29a2ecf77b9Product name320190215

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-0581-12020-01-31C16284748780-19d75b9d0-d399-f424-e053-dadaa90a57ceBenzonatate Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0581-1benzonatate15 in 1 BOTTLECAPSULE152

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
benzonatateACTIVE INGREDIENT5P4DHS6ENRBENZONATATE CAPSULE [REDPHARM DRUG INC.]2
benzonatateACTIVE MOIETY5P4DHS6ENRBENZONATATE CAPSULE [REDPHARM DRUG INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBENZONATATE CAPSULE [REDPHARM DRUG INC.]2
gelatinINACTIVE INGREDIENT2G86QN327LBENZONATATE CAPSULE [REDPHARM DRUG INC.]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXBENZONATATE CAPSULE [REDPHARM DRUG INC.]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9TBENZONATATE CAPSULE [REDPHARM DRUG INC.]2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHBENZONATATE CAPSULE [REDPHARM DRUG INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPBENZONATATE CAPSULE [REDPHARM DRUG INC.]2
waterINACTIVE INGREDIENT059QF0KO0RBENZONATATE CAPSULE [REDPHARM DRUG INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0581BENZONATATE CAPSULE [REDPHARM DRUG INC.]2Legacy NDC, 1 package rows20110706_a8861d0d-3ca8-4b46-adc5-5dd322142b96.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSNa8861d0d-3ca8-4b46-adc5-5dd322142b962
197397benzonatate 100 MG Oral CapsuleSCDa8861d0d-3ca8-4b46-adc5-5dd322142b962

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67296-0581-16729605810115 in 1 BOTTLEHistorical