Benzonatate

Product NDC
66116-513
11-digit product format
661160513
Labeler code
66116
Product ID
66116-513_edde25d4-9ac3-4b11-8b65-be221e06f37e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
MedVantx, Inc.
Application
ANDA081297
Marketing category
ANDA
Marketing start
2008-01-25
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
E
Listing certified through
2017-12-31
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
66116-513-302019-11-27C16284748780-19855d018-ebdc-cd31-e053-dbdaa90ab51aBENZONATATE CAPSULES USP, 100 mg and 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66116-513-30Benzonatate30 in 1 BOTTLECAPSULE301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZONATATEACTIVE INGREDIENT5P4DHS6ENRBENZONATATE CAPSULE [MEDVANTX, INC.]1
BENZONATATEACTIVE MOIETY5P4DHS6ENRBENZONATATE CAPSULE [MEDVANTX, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBENZONATATE CAPSULE [MEDVANTX, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LBENZONATATE CAPSULE [MEDVANTX, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBENZONATATE CAPSULE [MEDVANTX, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RBENZONATATE CAPSULE [MEDVANTX, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66116-513BENZONATATE CAPSULE [MEDVANTX, INC.]1Legacy NDC, 1 package rows20130409_edde25d4-9ac3-4b11-8b65-be221e06f37e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSNedde25d4-9ac3-4b11-8b65-be221e06f37e1
283417benzonatate 200 MG Oral CapsuleSCDedde25d4-9ac3-4b11-8b65-be221e06f37e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66116-513-306611605133030 in 1 BOTTLEHistorical