FDA.reportPublic FDA data

Clonazepam

Product NDC
71610-363
11-digit product format
716100363
Labeler code
71610
Product ID
71610-363_4920f458-d8f5-4089-a4b4-8cdcfe210de3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077856
Marketing category
ANDA
Marketing start
2018-02-15
Marketing end
0000-00-00
Substance
CLONAZEPAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f8e2a02d-e7b1-29aa-eb39-98a679441d91Product name320190927
dc4336d1-53d4-d410-38d3-71aa2ce4749bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71610-363-152023-01-30C16284748780-1f386c649-a710-0266-e053-dadaa90a7c1aCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
71610-363-282023-01-30C16284748780-1f386c649-a710-0266-e053-dadaa90a7c1aCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
71610-363-302023-01-30C16284748780-1f386c649-a710-0266-e053-dadaa90a7c1aCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
71610-363-452023-01-30C16284748780-1f386c649-a710-0266-e053-dadaa90a7c1aCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
71610-363-462023-01-30C16284748780-1f386c649-a710-0266-e053-dadaa90a7c1aCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
71610-363-532023-01-30C16284748780-1f386c649-a710-0266-e053-dadaa90a7c1aCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
71610-363-602023-01-30C16284748780-1f386c649-a710-0266-e053-dadaa90a7c1aCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
71610-363-702023-01-30C16284748780-1f386c649-a710-0266-e053-dadaa90a7c1aCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
71610-363-752023-01-30C16284748780-1f386c649-a710-0266-e053-dadaa90a7c1aCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
71610-363-802023-01-30C16284748780-1f386c649-a710-0266-e053-dadaa90a7c1aCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-363-15Clonazepam15 in 1 BOTTLE, PLASTICTABLET151
71610-363-28Clonazepam28 in 1 BOTTLE, PLASTICTABLET281
71610-363-30Clonazepam30 in 1 BOTTLE, PLASTICTABLET301
71610-363-45Clonazepam45 in 1 BOTTLE, PLASTICTABLET451
71610-363-46Clonazepam56 in 1 BOTTLE, PLASTICTABLET561
71610-363-53Clonazepam60 in 1 BOTTLE, PLASTICTABLET601
71610-363-60Clonazepam90 in 1 BOTTLE, PLASTICTABLET901
71610-363-70Clonazepam120 in 1 BOTTLE, PLASTICTABLET1201
71610-363-75Clonazepam150 in 1 BOTTLE, PLASTICTABLET1501
71610-363-80Clonazepam180 in 1 BOTTLE, PLASTICTABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-363-15EA - Each71610-363dde0ea7e-d9aa-4bee-b16b-3fef21c67e7112020-01-03
71610-363-28EA - Each71610-36315a04cc3-e436-4971-8680-562b1b0f210c12020-01-03
71610-363-30EA - Each71610-36395f08f67-ca65-4ef9-a84f-cb46cbfa876e12020-01-03
71610-363-45EA - Each71610-363b2214ba7-c77b-4353-a2df-1d59ec1ad70112020-01-03
71610-363-46EA - Each71610-363d20d17dc-d0b2-42d2-9695-199e7a7a0e6f12020-01-03
71610-363-53EA - Each71610-363f2432308-79b0-4587-ab2e-18afc5172ddf12020-01-03
71610-363-60EA - Each71610-363bb9676ec-2098-4877-83f9-2cc00c10c40612020-01-03
71610-363-70EA - Each71610-3639b28a3b9-77b8-41be-bddc-2f2478c8e1ec12020-01-03
71610-363-75EA - Each71610-3634c7fb9be-033b-4c4f-99ef-6ee5660753b412020-01-03
71610-363-80EA - Each71610-3637b2d0df8-67bf-4fb6-a331-cba69bc0decd12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-363CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 10 package rows20191128_37666d94-0898-4656-9c08-f6d1f5491406.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197528clonazePAM 1 MG Oral TabletPSN37666d94-0898-4656-9c08-f6d1f54914061
197528clonazepam 1 MG Oral TabletSCD37666d94-0898-4656-9c08-f6d1f54914061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-363-157161003631515 TABLET in 1 BOTTLE, PLASTIC (71610-363-15) 15 tablet2019-11-180000-00-00NoNoCurrent
71610-363-287161003632828 TABLET in 1 BOTTLE, PLASTIC (71610-363-28) 28 tablet2019-11-180000-00-00NoNoCurrent
71610-363-307161003633030 TABLET in 1 BOTTLE, PLASTIC (71610-363-30) 30 tablet2019-11-180000-00-00NoNoCurrent
71610-363-457161003634545 TABLET in 1 BOTTLE, PLASTIC (71610-363-45) 45 tablet2019-11-180000-00-00NoNoCurrent
71610-363-467161003634656 TABLET in 1 BOTTLE, PLASTIC (71610-363-46) 56 tablet2019-11-180000-00-00NoNoCurrent
71610-363-537161003635360 TABLET in 1 BOTTLE, PLASTIC (71610-363-53) 60 tablet2019-11-180000-00-00NoNoCurrent
71610-363-607161003636090 TABLET in 1 BOTTLE, PLASTIC (71610-363-60) 90 tablet2019-11-180000-00-00NoNoCurrent
71610-363-7071610036370120 TABLET in 1 BOTTLE, PLASTIC (71610-363-70) 120 tablet2019-11-180000-00-00NoNoCurrent
71610-363-7571610036375150 TABLET in 1 BOTTLE, PLASTIC (71610-363-75) 150 tablet2019-11-180000-00-00NoNoCurrent
71610-363-8071610036380180 TABLET in 1 BOTTLE, PLASTIC (71610-363-80) 180 tablet2019-11-180000-00-00NoNoCurrent