benzonatate

Product NDC
10544-123
11-digit product format
105440123
Labeler code
10544
Product ID
10544-123_0ff56761-89ec-5239-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
2013-07-10
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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
dc429dc2-e942-6686-8d72-b63c57e806aaProduct name520190416
d45c2ed6-126c-dd22-afd2-e29a2ecf77b9Product name320190215

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-123-20benzonatate20 in 1 BOTTLECAPSULE204
10544-123-30benzonatate30 in 1 BOTTLECAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-123-20EA - Each10544-1238f2722d9-d03e-46cf-8f1a-fb9d3b4b8df712015-10-02
10544-123-30EA - Each10544-123ca6ad213-9440-4674-8324-5e3ee4977cd712015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZONATATEACTIVE INGREDIENT5P4DHS6ENRBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]4
BENZONATATEACTIVE MOIETY5P4DHS6ENRBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]4
GELATININACTIVE INGREDIENT2G86QN327LBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-123BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]4Legacy NDC, 2 package rows20150226_00acfc04-3ad0-487e-87dd-e6e632c05b45.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN00acfc04-3ad0-487e-87dd-e6e632c05b454
283417benzonatate 200 MG Oral CapsulePSN00acfc04-3ad0-487e-87dd-e6e632c05b454
197397benzonatate 100 MG Oral CapsuleSCD00acfc04-3ad0-487e-87dd-e6e632c05b454
283417benzonatate 200 MG Oral CapsuleSCD00acfc04-3ad0-487e-87dd-e6e632c05b454

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-123-201054401232020 in 1 BOTTLEHistorical
10544-123-301054401233030 in 1 BOTTLEHistorical