FDA.reportPublic FDA data

Clonazepam

Product NDC
71610-852
11-digit product format
716100852
Labeler code
71610
Product ID
71610-852_20b33aac-b9ba-2743-e063-6294a90ae043
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075150
Marketing category
ANDA
Marketing start
2023-01-17
Substance
CLONAZEPAM
Active strength
1 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
CLONAZEPAM1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5PE9FDE8GB
Rxcui197528

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
71610-852-12Clonazepam12 in 1 BOTTLETABLET121
71610-852-15Clonazepam15 in 1 BOTTLETABLET151
71610-852-28Clonazepam28 in 1 BOTTLETABLET281
71610-852-30Clonazepam30 in 1 BOTTLETABLET301
71610-852-45Clonazepam45 in 1 BOTTLETABLET451
71610-852-46Clonazepam56 in 1 BOTTLETABLET561
71610-852-53Clonazepam60 in 1 BOTTLETABLET601
71610-852-60Clonazepam90 in 1 BOTTLETABLET901
71610-852-80Clonazepam180 in 1 BOTTLETABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-852-12EA - Each71610-8524eed5a5f-6c8a-4934-8d29-7fbfe59b988112024-10-04
71610-852-15EA - Each71610-852145573fe-970e-471c-82d8-b774725950f912024-10-04
71610-852-28EA - Each71610-852c8e360f2-1be4-4877-bc10-0b10e1e822ad12024-10-04
71610-852-30EA - Each71610-8522fe74271-f7c2-4dd6-a914-155ea223a57912024-10-04
71610-852-45EA - Each71610-852ec6b5453-5375-41f3-8c44-83443d9ea5ce12024-10-04
71610-852-46EA - Each71610-852b598d8bf-fd46-40ae-b827-18be30a2a84b12024-10-04
71610-852-53EA - Each71610-85225bec7f0-a23e-49db-aa70-6e979b092e2112024-10-04
71610-852-60EA - Each71610-85244147e19-3771-4fc0-a2c7-82a9b22e602112024-10-04
71610-852-80EA - Each71610-852c4b8a4eb-13c9-4746-bc55-ae466c8e58ae12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-852CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]1Current NDC, 9 package rows20240831_20b3125e-4489-3c53-e063-6294a90a6539.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197528clonazePAM 1 MG Oral TabletPSN20b3125e-4489-3c53-e063-6294a90a65391
197528clonazepam 1 MG Oral TabletSCD20b3125e-4489-3c53-e063-6294a90a65391

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-852-127161008521212 TABLET in 1 BOTTLE (71610-852-12) 12 tablet2024-08-27NoNoHistorical
71610-852-157161008521515 TABLET in 1 BOTTLE (71610-852-15) 15 tablet2024-08-28NoNoHistorical
71610-852-287161008522828 TABLET in 1 BOTTLE (71610-852-28) 28 tablet2024-08-27NoNoHistorical
71610-852-307161008523030 TABLET in 1 BOTTLE (71610-852-30) 30 tablet2024-08-27NoNoHistorical
71610-852-457161008524545 TABLET in 1 BOTTLE (71610-852-45) 45 tablet2024-08-27NoNoHistorical
71610-852-467161008524656 TABLET in 1 BOTTLE (71610-852-46) 56 tablet2024-08-27NoNoHistorical
71610-852-537161008525360 TABLET in 1 BOTTLE (71610-852-53) 60 tablet2024-08-27NoNoHistorical
71610-852-607161008526090 TABLET in 1 BOTTLE (71610-852-60) 90 tablet2024-08-27NoNoHistorical
71610-852-8071610085280180 TABLET in 1 BOTTLE (71610-852-80) 180 tablet2024-08-27NoNoHistorical