FDA.reportPublic FDA data

Clonazepam

Product NDC
71610-790
11-digit product format
716100790
Labeler code
71610
Product ID
71610-790_2528d6db-eb77-3ccc-e063-6294a90a3022
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075468
Marketing category
ANDA
Marketing start
2022-04-14
Substance
CLONAZEPAM
Active strength
.5 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clonazepam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONAZEPAM.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5PE9FDE8GB
Rxcui197527

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-790-10Clonazepam10 in 1 BOTTLETABLET102
71610-790-15Clonazepam15 in 1 BOTTLETABLET152
71610-790-20Clonazepam20 in 1 BOTTLETABLET202
71610-790-28Clonazepam28 in 1 BOTTLETABLET282
71610-790-30Clonazepam30 in 1 BOTTLETABLET302
71610-790-45Clonazepam45 in 1 BOTTLETABLET452
71610-790-46Clonazepam56 in 1 BOTTLETABLET562
71610-790-53Clonazepam60 in 1 BOTTLETABLET602
71610-790-55Clonazepam75 in 1 BOTTLETABLET752
71610-790-60Clonazepam90 in 1 BOTTLETABLET902
71610-790-70Clonazepam120 in 1 BOTTLETABLET1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-790-10EA - Each71610-79018025a4e-313f-4ce8-ad86-ab0adb321c0e12024-12-10
71610-790-15EA - Each71610-790b1a7442a-6607-459b-9cf0-67e1ab17736e12024-03-12
71610-790-20EA - Each71610-790f36bac86-a733-417c-a5b6-4880d6eed73512024-03-12
71610-790-28EA - Each71610-79050adf8e5-0377-47a6-b2de-ba6ce5dafa2612024-03-12
71610-790-30EA - Each71610-79017a90a23-970b-4d6d-8e71-a4a93a6c5fce12024-12-10
71610-790-45EA - Each71610-790d3f9a9ff-3ef8-42fa-91c4-5da710d83e8712024-12-10
71610-790-46EA - Each71610-790f6e92017-d644-4cde-8bae-5505ed10bd1812024-12-10
71610-790-53EA - Each71610-790d4ae463b-f097-4238-9c21-bba3878337dc12024-12-10
71610-790-55EA - Each71610-790a6827aa7-cb7a-4abb-ab22-5679493daad712024-03-12
71610-790-60EA - Each71610-790bfb0d53e-b6a4-4c49-be75-6830e942371e12024-03-12
71610-790-70EA - Each71610-7907dc229b5-2b09-46a5-ba9d-b2807d4436d412024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-790CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, 11 package rows20241031_8891c5aa-f42a-4206-92b9-f0ed0631dfcb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197527clonazePAM 0.5 MG Oral TabletPSN8891c5aa-f42a-4206-92b9-f0ed0631dfcb2
197527clonazepam 0.5 MG Oral TabletSCD8891c5aa-f42a-4206-92b9-f0ed0631dfcb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-790-107161007901010 TABLET in 1 BOTTLE (71610-790-10) 10 tablet2024-10-23NoNoHistorical
71610-790-157161007901515 TABLET in 1 BOTTLE (71610-790-15) 15 tablet2024-01-25NoNoHistorical
71610-790-207161007902020 TABLET in 1 BOTTLE (71610-790-20) 20 tablet2024-02-05NoNoHistorical
71610-790-287161007902828 TABLET in 1 BOTTLE (71610-790-28) 28 tablet2024-01-25NoNoHistorical
71610-790-307161007903030 TABLET in 1 BOTTLE (71610-790-30) 30 tablet2024-10-23NoNoHistorical
71610-790-457161007904545 TABLET in 1 BOTTLE (71610-790-45) 45 tablet2024-10-23NoNoHistorical
71610-790-467161007904656 TABLET in 1 BOTTLE (71610-790-46) 56 tablet2024-10-23NoNoHistorical
71610-790-537161007905360 TABLET in 1 BOTTLE (71610-790-53) 60 tablet2024-10-23NoNoHistorical
71610-790-557161007905575 TABLET in 1 BOTTLE (71610-790-55) 75 tablet2024-01-25NoNoHistorical
71610-790-607161007906090 TABLET in 1 BOTTLE (71610-790-60) 90 tablet2024-01-25NoNoHistorical
71610-790-7071610079070120 TABLET in 1 BOTTLE (71610-790-70) 120 tablet2024-01-25NoNoHistorical