FDA.reportPublic FDA data

Clonazepam

Product NDC
71610-368
11-digit product format
716100368
Labeler code
71610
Product ID
71610-368_24759da4-f035-bb20-e063-6294a90abca9
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
71610-368-10Clonazepam10 in 1 BOTTLE, PLASTICTABLET103
71610-368-14Clonazepam14 in 1 BOTTLE, PLASTICTABLET143
71610-368-15Clonazepam15 in 1 BOTTLE, PLASTICTABLET153
71610-368-20Clonazepam20 in 1 BOTTLE, PLASTICTABLET203
71610-368-28Clonazepam28 in 1 BOTTLE, PLASTICTABLET283
71610-368-30Clonazepam30 in 1 BOTTLE, PLASTICTABLET303
71610-368-45Clonazepam45 in 1 BOTTLE, PLASTICTABLET453
71610-368-46Clonazepam56 in 1 BOTTLE, PLASTICTABLET563
71610-368-53Clonazepam60 in 1 BOTTLE, PLASTICTABLET603
71610-368-54Clonazepam84 in 1 BOTTLE, PLASTICTABLET843
71610-368-55Clonazepam75 in 1 BOTTLE, PLASTICTABLET753
71610-368-60Clonazepam90 in 1 BOTTLE, PLASTICTABLET903
71610-368-70Clonazepam120 in 1 BOTTLE, PLASTICTABLET1203
71610-368-75Clonazepam150 in 1 BOTTLE, PLASTICTABLET1503
71610-368-80Clonazepam180 in 1 BOTTLE, PLASTICTABLET1803
71610-368-92Clonazepam270 in 1 BOTTLE, PLASTICTABLET2703

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-368-10EA - Each71610-368a3d69048-b208-4257-b04a-6072fc84e5a712020-07-13
71610-368-14EA - Each71610-368cf3442c8-1700-474d-ac18-70da5d16ab3d12020-07-13
71610-368-15EA - Each71610-368a77cadb5-1157-48d0-b427-3bde56a6b88a12020-07-13
71610-368-20EA - Each71610-368132aebbc-757a-49eb-bd8e-503d023124bc12020-07-13
71610-368-28EA - Each71610-3688c8f0502-bf98-44eb-91f9-9ac6b1fdf27412020-07-13
71610-368-30EA - Each71610-368d8bf70cb-3367-43f7-a5b7-602c39510d5c12020-07-13
71610-368-45EA - Each71610-36845c9c287-3ad9-489a-be91-c3b272796ce712020-07-13
71610-368-46EA - Each71610-3687392d408-a827-496f-b1f4-c6f3c04f0e4d12024-12-10
71610-368-53EA - Each71610-3686f1f7d06-4507-47ea-bb89-f89a793cf3f212020-01-03
71610-368-54EA - Each71610-368ec40d30b-0d7d-4eaa-ad26-a4f2ca22e2bc12020-07-13
71610-368-55EA - Each71610-3687f7afb69-bfee-4594-b1a9-227aef6620a212020-07-13
71610-368-60EA - Each71610-368ea945e62-b05c-419f-b5c5-f5aecb4fb62012020-01-03
71610-368-70EA - Each71610-3680684707f-cd6a-4569-8c88-7b6f4ef9019812020-02-13
71610-368-75EA - Each71610-368bea1717b-82a0-4d56-a135-09fbbd0e7e5b12020-07-13
71610-368-80EA - Each71610-3686c2f54bc-1e9d-442e-9a33-a43b2a219fad12020-07-13
71610-368-92EA - Each71610-368d60a9626-83f9-45a5-b128-d2eec1ef367712020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-368CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Current NDC, Legacy NDC, 16 package rows20241017_66bf60fa-61ac-47a7-a081-36077af9007e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197527clonazePAM 0.5 MG Oral TabletPSN66bf60fa-61ac-47a7-a081-36077af9007e3
197527clonazepam 0.5 MG Oral TabletSCD66bf60fa-61ac-47a7-a081-36077af9007e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-368-107161003681010 TABLET in 1 BOTTLE, PLASTIC (71610-368-10) 10 tablet2020-03-260000-00-00NoNoCurrent
71610-368-147161003681414 TABLET in 1 BOTTLE, PLASTIC (71610-368-14) 14 tablet2020-03-260000-00-00NoNoCurrent
71610-368-157161003681515 TABLET in 1 BOTTLE, PLASTIC (71610-368-15) 15 tablet2020-03-120000-00-00NoNoCurrent
71610-368-207161003682020 TABLET in 1 BOTTLE, PLASTIC (71610-368-20) 20 tablet2020-03-260000-00-00NoNoCurrent
71610-368-287161003682828 TABLET in 1 BOTTLE, PLASTIC (71610-368-28) 28 tablet2020-01-290000-00-00NoNoCurrent
71610-368-307161003683030 TABLET in 1 BOTTLE, PLASTIC (71610-368-30) 30 tablet2020-03-120000-00-00NoNoCurrent
71610-368-457161003684545 TABLET in 1 BOTTLE, PLASTIC (71610-368-45) 45 tablet2020-03-120000-00-00NoNoCurrent
71610-368-467161003684656 TABLET in 1 BOTTLE, PLASTIC (71610-368-46) 56 tablet2024-10-14NoNoHistorical
71610-368-537161003685360 TABLET in 1 BOTTLE, PLASTIC (71610-368-53) 60 tablet2019-11-200000-00-00NoNoCurrent
71610-368-547161003685484 TABLET in 1 BOTTLE, PLASTIC (71610-368-54) 84 tablet2020-01-290000-00-00NoNoCurrent
71610-368-557161003685575 TABLET in 1 BOTTLE, PLASTIC (71610-368-55) 75 tablet2020-05-080000-00-00NoNoCurrent
71610-368-607161003686090 TABLET in 1 BOTTLE, PLASTIC (71610-368-60) 90 tablet2019-11-200000-00-00NoNoCurrent
71610-368-7071610036870120 TABLET in 1 BOTTLE, PLASTIC (71610-368-70) 120 tablet2019-12-040000-00-00NoNoCurrent
71610-368-7571610036875150 TABLET in 1 BOTTLE, PLASTIC (71610-368-75) 150 tablet2020-04-230000-00-00NoNoCurrent
71610-368-8071610036880180 TABLET in 1 BOTTLE, PLASTIC (71610-368-80) 180 tablet2020-04-030000-00-00NoNoCurrent
71610-368-9271610036892270 TABLET in 1 BOTTLE, PLASTIC (71610-368-92) 270 tablet2019-12-040000-00-00NoNoCurrent