FDA.reportPublic FDA data

Clonazepam

Product NDC
71610-863
11-digit product format
716100863
Labeler code
71610
Product ID
71610-863_26e544ba-44b8-cc65-e063-6394a90a2d64
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
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
71610-863-10Clonazepam10 in 1 BOTTLETABLET102
71610-863-15Clonazepam15 in 1 BOTTLETABLET152
71610-863-20Clonazepam20 in 1 BOTTLETABLET202
71610-863-28Clonazepam28 in 1 BOTTLETABLET282
71610-863-30Clonazepam30 in 1 BOTTLETABLET302
71610-863-45Clonazepam45 in 1 BOTTLETABLET452
71610-863-46Clonazepam56 in 1 BOTTLETABLET562
71610-863-53Clonazepam60 in 1 BOTTLETABLET602
71610-863-54Clonazepam84 in 1 BOTTLETABLET842
71610-863-55Clonazepam75 in 1 BOTTLETABLET752
71610-863-60Clonazepam90 in 1 BOTTLETABLET902
71610-863-70Clonazepam120 in 1 BOTTLETABLET1202
71610-863-80Clonazepam180 in 1 BOTTLETABLET1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-863-10EA - Each71610-863721f6ecb-48c5-4fe3-b169-7ebaf34cac2112025-02-10
71610-863-15EA - Each71610-8633fbcc903-627d-4519-9466-0570564174e012025-02-10
71610-863-20EA - Each71610-863efdd9973-62e7-4be2-bb31-e62d78a447fe12025-02-10
71610-863-28EA - Each71610-86367d18265-b015-433d-a1ac-98b3b4b9c28512025-02-10
71610-863-30EA - Each71610-863def87992-1a3d-47c8-a916-eb107bc877e712025-02-10
71610-863-45EA - Each71610-8637c3520a0-b430-4a90-903d-80caf6b1431e12025-02-10
71610-863-46EA - Each71610-86389dc3aa4-f85f-42d0-aa4e-f38fd753c2b412025-02-10
71610-863-53EA - Each71610-863b76a75e8-f9df-4b2c-8b90-9272e07b47ad12025-02-10
71610-863-54EA - Each71610-86394bc4ac6-5022-494d-b844-c9d2d6bb675c12025-02-10
71610-863-55EA - Each71610-86346feda0e-4e62-420b-94f6-c95930d455bf12025-02-10
71610-863-70EA - Each71610-863f1c86904-1345-4a2e-9236-c2b907054f3512025-02-10
71610-863-80EA - Each71610-86374598680-596d-45cd-933f-062a77eaee1b12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-863CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]2Current NDC, 13 package rows20241116_263f99eb-9744-5601-e063-6394a90a47b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197527clonazePAM 0.5 MG Oral TabletPSN263f99eb-9744-5601-e063-6394a90a47b12
197527clonazepam 0.5 MG Oral TabletSCD263f99eb-9744-5601-e063-6394a90a47b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-863-107161008631010 TABLET in 1 BOTTLE (71610-863-10) 10 tablet2024-11-04NoNoHistorical
71610-863-157161008631515 TABLET in 1 BOTTLE (71610-863-15) 15 tablet2024-11-04NoNoHistorical
71610-863-207161008632020 TABLET in 1 BOTTLE (71610-863-20) 20 tablet2024-11-13NoNoHistorical
71610-863-287161008632828 TABLET in 1 BOTTLE (71610-863-28) 28 tablet2024-11-13NoNoHistorical
71610-863-307161008633030 TABLET in 1 BOTTLE (71610-863-30) 30 tablet2024-11-04NoNoHistorical
71610-863-457161008634545 TABLET in 1 BOTTLE (71610-863-45) 45 tablet2024-11-04NoNoHistorical
71610-863-467161008634656 TABLET in 1 BOTTLE (71610-863-46) 56 tablet2024-11-04NoNoHistorical
71610-863-537161008635360 TABLET in 1 BOTTLE (71610-863-53) 60 tablet2024-11-04NoNoHistorical
71610-863-547161008635484 TABLET in 1 BOTTLE (71610-863-54) 84 tablet2024-11-13NoNoHistorical
71610-863-557161008635575 TABLET in 1 BOTTLE (71610-863-55) 75 tablet2024-11-13NoNoHistorical
71610-863-607161008636090 TABLET in 1 BOTTLE (71610-863-60) 90 tablet2024-11-04NoNoHistorical
71610-863-7071610086370120 TABLET in 1 BOTTLE (71610-863-70) 120 tablet2024-11-04NoNoHistorical
71610-863-8071610086380180 TABLET in 1 BOTTLE (71610-863-80) 180 tablet2024-11-04NoNoHistorical