benzonatate

Product NDC
63187-016
11-digit product format
631870016
Labeler code
63187
Product ID
63187-016_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
100 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
63187-016-20EA - Each63187-0166116b43c-155f-4add-aef5-7fd5853f568312017-03-06
63187-016-30EA - Each63187-016102e1d0f-d5d0-401b-96e1-58194ba1550812023-09-05
63187-016-40EA - Each63187-016e2530bdb-29a3-44e5-80b3-668632a30b7212017-07-07

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
63187-016BENZONATATE 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
63187-016-106318700161010 CAPSULE in 1 BOTTLE (63187-016-10) 10 capsule2017-09-010000-00-00NoNoCurrent
63187-016-156318700161515 CAPSULE in 1 BOTTLE (63187-016-15) 15 capsule2014-04-010000-00-00NoNoCurrent
63187-016-206318700162020 CAPSULE in 1 BOTTLE (63187-016-20) 20 capsule2014-04-010000-00-00NoNoCurrent
63187-016-306318700163030 CAPSULE in 1 BOTTLE (63187-016-30) 30 capsule2015-04-010000-00-00NoNoCurrent
63187-016-406318700164040 CAPSULE in 1 BOTTLE (63187-016-40) 40 capsule2016-11-010000-00-00NoNoCurrent