FDA.reportPublic FDA data

benzonatate

Product NDC
67877-128
11-digit product format
678770128
Labeler code
67877
Product ID
67877-128_de64cd7e-65b6-4ba2-8ed7-a1c98f2cca4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Ascend Laboratories LLC
Application
ANDA201209
Marketing category
ANDA
Marketing start
2015-02-09
Marketing end
0000-00-00
Substance
BENZONATATE
Active strength
150 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 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
67877-128-012021-07-23C16284748780-1c7ccaba7-1638-fd44-e053-dadaa90aa01bBenzonatate Capsules, USP 100 mg, 150 mg and 200 mg
67877-128-052021-07-23C16284748780-1c7ccaba7-1638-fd44-e053-dadaa90aa01bBenzonatate Capsules, USP 100 mg, 150 mg and 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-128-01benzonatate100 in 1 BOTTLECAPSULE10013
67877-128-05benzonatate500 in 1 BOTTLECAPSULE50013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-128-01EA - Each67877-128d93fc4c9-c1eb-4b7a-b97e-e73d2b946b1812015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
benzonatateACTIVE INGREDIENT5P4DHS6ENRBENZONATATE CAPSULE [ASCEND LABORATORIES LLC]11
benzonatateACTIVE MOIETY5P4DHS6ENRBENZONATATE CAPSULE [ASCEND LABORATORIES LLC]11
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBENZONATATE CAPSULE [ASCEND LABORATORIES LLC]11
gelatinINACTIVE INGREDIENT2G86QN327LBENZONATATE CAPSULE [ASCEND LABORATORIES LLC]11
glycerinINACTIVE INGREDIENTPDC6A3C0OXBENZONATATE CAPSULE [ASCEND LABORATORIES LLC]11
methylparabenINACTIVE INGREDIENTA2I8C7HI9TBENZONATATE CAPSULE [ASCEND LABORATORIES LLC]11
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHBENZONATATE CAPSULE [ASCEND LABORATORIES LLC]11
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPBENZONATATE CAPSULE [ASCEND LABORATORIES LLC]11
waterINACTIVE INGREDIENT059QF0KO0RBENZONATATE CAPSULE [ASCEND LABORATORIES LLC]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-128BENZONATATE CAPSULE [ASCEND LABORATORIES LLC]13Legacy NDC, 2 package rows20200101_27388883-e698-4501-b8c9-78c76ae9b1e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN27388883-e698-4501-b8c9-78c76ae9b1e113
903291benzonatate 150 MG Oral CapsulePSN27388883-e698-4501-b8c9-78c76ae9b1e113
283417benzonatate 200 MG Oral CapsulePSN27388883-e698-4501-b8c9-78c76ae9b1e113
197397benzonatate 100 MG Oral CapsuleSCD27388883-e698-4501-b8c9-78c76ae9b1e113
903291benzonatate 150 MG Oral CapsuleSCD27388883-e698-4501-b8c9-78c76ae9b1e113
283417benzonatate 200 MG Oral CapsuleSCD27388883-e698-4501-b8c9-78c76ae9b1e113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-128-0167877012801100 CAPSULE in 1 BOTTLE (67877-128-01) 100 capsule2015-02-090000-00-00NoNoCurrent
67877-128-0567877012805500 CAPSULE in 1 BOTTLE (67877-128-05) 500 capsule2015-02-090000-00-00NoNoCurrent