benzonatate

Product NDC
70934-078
11-digit product format
709340078
Labeler code
70934
Product ID
70934-078_b815406b-b482-59af-e053-2995a90a9aa6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA040749
Marketing category
ANDA
Marketing start
2018-02-09
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
2022-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-078-20benzonatate20 in 1 BOTTLE, PLASTICCAPSULE203
70934-078-30benzonatate30 in 1 BOTTLE, PLASTICCAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-078-20EA - Each70934-0783e775fc8-0135-4e6a-862e-981df734149912018-05-09
70934-078-30EA - Each70934-078289e7385-c642-454f-abe7-95bbd93d8ca912018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-078BENZONATATE CAPSULE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]3Legacy NDC, 2 package rows20210105_691cee22-9e7a-ffdb-e053-2a91aa0aa08e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSN691cee22-9e7a-ffdb-e053-2a91aa0aa08e3
283417benzonatate 200 MG Oral CapsuleSCD691cee22-9e7a-ffdb-e053-2a91aa0aa08e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-078-207093400782020 CAPSULE in 1 BOTTLE, PLASTIC (70934-078-20) 20 capsule2018-02-090000-00-00NoNoCurrent
70934-078-307093400783030 CAPSULE in 1 BOTTLE, PLASTIC (70934-078-30) 30 capsule2018-02-090000-00-00NoNoCurrent