benzonatate

Product NDC
0904-6657
11-digit product format
009046657
Labeler code
0904
Product ID
0904-6657_e5fa3d97-4f4b-4a7d-bd65-d2aa68233ad2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA040627
Marketing category
ANDA
Marketing start
2017-03-22
Marketing end
2023-06-30
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
0000-00-00
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
0904-6657-602021-10-07C16284748780-1ba0f9c33-40fb-a910-e053-dadaa90a0b858b0024a3-7b24-454f-aa05-36357595c312
0904-6657-602021-01-29C16284748780-1ba0f9c33-40fb-a910-e053-dadaa90a0b858b0024a3-7b24-454f-aa05-36357595c312

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6657-60EA - Each0904-66577a9dc79e-b7b2-4345-b1f0-6d4d8fcbc33112017-10-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSNafd8e604-072a-63d1-e053-2995a90a76821
197397benzonatate 100 MG Oral CapsuleSCDafd8e604-072a-63d1-e053-2995a90a76821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6657-6000904665760100 CAPSULE in 1 BOTTLE (0904-6657-60) 100 capsule2017-03-222023-06-30NoNoCurrent