BENZONATATE

Product NDC
61919-031
11-digit product format
619190031
Labeler code
61919
Product ID
61919-031_9c5989ca-d5f1-aaa1-e053-2a95a90a5b35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BENZONATATE
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA040627
Marketing category
ANDA
Marketing start
2014-01-01
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
2021-12-31
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
61919-031-202023-01-30C16284748780-1f386c649-a092-0266-e053-dadaa90a7c1aBENZONATATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-031-20BENZONATATE20 in 1 BOTTLECAPSULE204
61919-031-30BENZONATATE30 in 1 BOTTLECAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-031-20EA - Each61919-031192237d7-6fac-426b-b801-fc65700c9f4812018-03-08
61919-031-30EA - Each61919-031e84ebe96-3293-4b73-9e86-13f61fdc13d112014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZONATATEACTIVE INGREDIENT5P4DHS6ENRBENZONATATE CAPSULE [DIRECT RX]1
BENZONATATEACTIVE MOIETY5P4DHS6ENRBENZONATATE CAPSULE [DIRECT RX]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBENZONATATE CAPSULE [DIRECT RX]1
GELATININACTIVE INGREDIENT2G86QN327LBENZONATATE CAPSULE [DIRECT RX]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBENZONATATE CAPSULE [DIRECT RX]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBENZONATATE CAPSULE [DIRECT RX]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBENZONATATE CAPSULE [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENZONATATE CAPSULE [DIRECT RX]1
WATERINACTIVE INGREDIENT059QF0KO0RBENZONATATE CAPSULE [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-031BENZONATATE CAPSULE [DIRECT RX]4Legacy NDC, 2 package rows20200118_e2f9df12-891f-43be-90fb-0ca38e72d3df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSNe2f9df12-891f-43be-90fb-0ca38e72d3df4
197397benzonatate 100 MG Oral CapsuleSCDe2f9df12-891f-43be-90fb-0ca38e72d3df4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-031-206191900312020 BOTTLE in 1 BOTTLE (61919-031-20) > 30 CAPSULE in 1 BOTTLE (61919-031-30) 20 bottle2014-03-240000-00-00NoNoCurrent
61919-031-306191900313030 in 1 BOTTLEHistorical