benzonatate

Product NDC
63187-185
11-digit product format
631870185
Labeler code
63187
Product ID
63187-185_b81d0eb4-1112-4371-aa8b-afa80ff03ab5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040627
Marketing category
ANDA
Marketing start
2007-07-25
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
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-185-10EA - Each63187-1852a669d43-d516-432c-afe5-b0d5aa0647cb12017-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
benzonatateACTIVE INGREDIENT5P4DHS6ENRBENZONATATE CAPSULE [PROFICIENT RX LP]4
benzonatateACTIVE MOIETY5P4DHS6ENRBENZONATATE CAPSULE [PROFICIENT RX LP]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBENZONATATE CAPSULE [PROFICIENT RX LP]4
gelatinINACTIVE INGREDIENT2G86QN327LBENZONATATE CAPSULE [PROFICIENT RX LP]4
glycerinINACTIVE INGREDIENTPDC6A3C0OXBENZONATATE CAPSULE [PROFICIENT RX LP]4
methylparabenINACTIVE INGREDIENTA2I8C7HI9TBENZONATATE CAPSULE [PROFICIENT RX LP]4
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHBENZONATATE CAPSULE [PROFICIENT RX LP]4
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPBENZONATATE CAPSULE [PROFICIENT RX LP]4
waterINACTIVE INGREDIENT059QF0KO0RBENZONATATE CAPSULE [PROFICIENT RX LP]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-185BENZONATATE CAPSULE [PROFICIENT RX LP]10Legacy NDC20191121_18a633e8-c285-49ce-88dd-1f46b140e4d4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-185-106318701851010 CAPSULE in 1 BOTTLE (63187-185-10) 10 capsule2017-09-010000-00-00NoNoCurrent
63187-185-146318701851414 CAPSULE in 1 BOTTLE (63187-185-14) 14 capsule2017-06-200000-00-00NoNoCurrent
63187-185-206318701852020 CAPSULE in 1 BOTTLE (63187-185-20) 20 capsule2014-07-010000-00-00NoNoCurrent
63187-185-216318701852121 CAPSULE in 1 BOTTLE (63187-185-21) 21 capsule2017-06-010000-00-00NoNoCurrent
63187-185-306318701853030 CAPSULE in 1 BOTTLE (63187-185-30) 30 capsule2014-07-010000-00-00NoNoCurrent
63187-185-406318701854040 CAPSULE in 1 BOTTLE (63187-185-40) 40 capsule2014-07-010000-00-00NoNoCurrent
63187-185-606318701856060 CAPSULE in 1 BOTTLE (63187-185-60) 60 capsule2014-07-010000-00-00NoNoCurrent