BENZONATATE

Product NDC
62332-427
11-digit product format
623320427
Labeler code
62332
Product ID
62332-427_21bb5698-b72c-4727-b9d4-39e18719fc16
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BENZONATATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA040682
Marketing category
ANDA
Marketing start
2018-05-01
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-427-31BENZONATATE100 in 1 BOTTLECAPSULE1005
62332-427-71BENZONATATE500 in 1 BOTTLECAPSULE5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-427-31EA - Each62332-427a5ab94d6-b6a0-407a-a02c-22994951e90712019-06-19
62332-427-71EA - Each62332-427cbd97b73-c289-4e2c-b226-4d8a95a3b7f412019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-427BENZONATATE CAPSULE [ALEMBIC PHARMACEUTICALS INC.]5Legacy NDC, 2 package rows20230124_c2d5bbc3-40a3-4b2f-9bc5-276acf21aa3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSN418c4c4e-6195-4d0d-a559-ee3f10147b5b101
283417benzonatate 200 MG Oral CapsuleSCD418c4c4e-6195-4d0d-a559-ee3f10147b5b101
197397benzonatate 100 MG Oral CapsulePSNc2d5bbc3-40a3-4b2f-9bc5-276acf21aa3e5
283417benzonatate 200 MG Oral CapsulePSNc2d5bbc3-40a3-4b2f-9bc5-276acf21aa3e5
197397benzonatate 100 MG Oral CapsuleSCDc2d5bbc3-40a3-4b2f-9bc5-276acf21aa3e5
283417benzonatate 200 MG Oral CapsuleSCDc2d5bbc3-40a3-4b2f-9bc5-276acf21aa3e5
283417benzonatate 200 MG Oral CapsulePSNf3c2be0c-3423-b9bc-e053-2a95a90ac3a82
283417benzonatate 200 MG Oral CapsuleSCDf3c2be0c-3423-b9bc-e053-2a95a90ac3a82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-427-3162332042731100 CAPSULE in 1 BOTTLE (62332-427-31) 100 capsule2018-05-010000-00-00NoNoCurrent
62332-427-7162332042771500 CAPSULE in 1 BOTTLE (62332-427-71) 500 capsule2018-05-010000-00-00NoNoCurrent