benzonatate

Product NDC
10544-094
11-digit product format
105440094
Labeler code
10544
Product ID
10544-094_11f47c1a-98c2-28eb-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA040749
Marketing category
ANDA
Marketing start
2013-01-14
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
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
10544-094-202020-01-31C16284748780-19d75b9d0-5a97-f424-e053-dadaa90a57ceBenzonatate Capsules, USP 100 mg, 150 mg and 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-094-20benzonatate20 in 1 BOTTLECAPSULE205

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZONATATEACTIVE INGREDIENT5P4DHS6ENRBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]5
BENZONATATEACTIVE MOIETY5P4DHS6ENRBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]5
GELATININACTIVE INGREDIENT2G86QN327LBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-094BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]5Legacy NDC, 1 package rows20150323_11f47c1a-98c1-28eb-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN11f47c1a-98c1-28eb-e054-00144ff88e885
197397benzonatate 100 MG Oral CapsuleSCD11f47c1a-98c1-28eb-e054-00144ff88e885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-094-201054400942020 in 1 BOTTLEHistorical