Benzonatate

Product NDC
70934-055
11-digit product format
709340055
Labeler code
70934
Product ID
70934-055_b8147a80-0e57-5dde-e053-2995a90a9d76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA202765
Marketing category
ANDA
Marketing start
2017-12-27
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70934-055-202023-01-30C16284748780-1f386c649-eeb3-0266-e053-dadaa90a7c1aBenzonatate Capsules USP, 100 mg and 200 mg
70934-055-302023-01-30C16284748780-1f386c649-eeb3-0266-e053-dadaa90a7c1aBenzonatate Capsules USP, 100 mg and 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-055-20Benzonatate20 in 1 BOTTLE, PLASTICCAPSULE203
70934-055-30Benzonatate30 in 1 BOTTLE, PLASTICCAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-055-20EA - Each70934-055fd9202c3-779e-4645-b11c-945743af806e12022-02-07
70934-055-30EA - Each70934-0553f8c5f17-10f9-4d72-ab3a-cae5c3dae1a812022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-055BENZONATATE CAPSULE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]3Legacy NDC, 2 package rows20210105_643ca3b8-8f99-27ca-e053-2a91aa0a4666.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSN643ca3b8-8f99-27ca-e053-2a91aa0a46663
283417benzonatate 200 MG Oral CapsuleSCD643ca3b8-8f99-27ca-e053-2a91aa0a46663

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-055-207093400552020 CAPSULE in 1 BOTTLE, PLASTIC (70934-055-20) 20 capsule2017-12-270000-00-00NoNoCurrent
70934-055-307093400553030 CAPSULE in 1 BOTTLE, PLASTIC (70934-055-30) 30 capsule2017-12-270000-00-00NoNoCurrent