Benzonatate

Product NDC
72865-118
11-digit product format
728650118
Labeler code
72865
Product ID
72865-118_ff2c1e5b-32ee-4c36-bf70-6aa9df252b01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
XLCare Pharmaceuticals, Inc.
Application
ANDA211518
Marketing category
ANDA
Marketing start
2020-02-17
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
2023-12-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72865-118-01Benzonatate100 in 1 BOTTLECAPSULE1003
72865-118-05Benzonatate500 in 1 BOTTLECAPSULE5003
72865-118-30Benzonatate30 in 1 BOTTLECAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-118-01EA - Each72865-118318ece98-0bdb-4426-b960-139986ebf0b312020-05-08
72865-118-05EA - Each72865-11891b4fc7b-6ac6-4f2b-8ff3-9f9442ef05b412020-05-08
72865-118-30EA - Each72865-1181e980f47-151f-4315-882c-7f4fdb5caaa112020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-118BENZONATATE CAPSULE [XLCARE PHARMACEUTICALS, INC.]2Legacy NDC, 3 package rows20220128_e33afd96-5ad3-4033-b067-981ac2ed2bea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSNe33afd96-5ad3-4033-b067-981ac2ed2bea3
903291benzonatate 150 MG Oral CapsulePSNe33afd96-5ad3-4033-b067-981ac2ed2bea3
283417benzonatate 200 MG Oral CapsulePSNe33afd96-5ad3-4033-b067-981ac2ed2bea3
197397benzonatate 100 MG Oral CapsuleSCDe33afd96-5ad3-4033-b067-981ac2ed2bea3
903291benzonatate 150 MG Oral CapsuleSCDe33afd96-5ad3-4033-b067-981ac2ed2bea3
283417benzonatate 200 MG Oral CapsuleSCDe33afd96-5ad3-4033-b067-981ac2ed2bea3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72865-118-0172865011801100 CAPSULE in 1 BOTTLE (72865-118-01) 100 capsule2020-02-170000-00-00NoNoCurrent
72865-118-0572865011805500 CAPSULE in 1 BOTTLE (72865-118-05) 500 capsule2020-02-170000-00-00NoNoCurrent
72865-118-307286501183030 CAPSULE in 1 BOTTLE (72865-118-30) 30 capsule2020-02-170000-00-00NoNoCurrent