Clonazepam

Product NDC
68788-8401
11-digit product format
687888401
Labeler code
68788
Product ID
68788-8401_f9ccda6a-4c5a-4acf-8a78-cb854f4f14e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077856
Marketing category
ANDA
Marketing start
2023-03-21
Substance
CLONAZEPAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clonazepam
Listing expiration
2027-12-31

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
68788-8401-2Clonazepam20 in 1 BOTTLE, PLASTICTABLET204
68788-8401-3Clonazepam30 in 1 BOTTLE, PLASTICTABLET304
68788-8401-6Clonazepam60 in 1 BOTTLE, PLASTICTABLET604
68788-8401-8Clonazepam28 in 1 BOTTLE, PLASTICTABLET284
68788-8401-9Clonazepam90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8401-2EA - Each68788-84012adcf45e-a2bc-41e5-8af7-30b747717f6812023-06-06
68788-8401-3EA - Each68788-84010c6df6db-1a05-4d01-9564-8c8bb1d0077412023-06-06
68788-8401-6EA - Each68788-8401303367da-fb17-474b-934b-fa7382fa28df12023-06-06
68788-8401-8EA - Each68788-8401da192958-84a8-4cb2-bfc7-a0edfd96f0d912023-06-06
68788-8401-9EA - Each68788-84014372a6c1-cf39-487c-bbe3-994e3e2a7bc712023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8401CLONAZEPAM TABLET [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 5 package rows20250308_87f362a7-cf66-4166-af51-ac2da473cf6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197528clonazePAM 1 MG Oral TabletPSN87f362a7-cf66-4166-af51-ac2da473cf6b4
197528clonazepam 1 MG Oral TabletSCD87f362a7-cf66-4166-af51-ac2da473cf6b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8401-26878884010220 TABLET in 1 BOTTLE, PLASTIC (68788-8401-2) 20 tablet2023-03-21NoNoHistorical
68788-8401-36878884010330 TABLET in 1 BOTTLE, PLASTIC (68788-8401-3) 30 tablet2023-03-21NoNoHistorical
68788-8401-66878884010660 TABLET in 1 BOTTLE, PLASTIC (68788-8401-6) 60 tablet2023-03-21NoNoHistorical
68788-8401-86878884010828 TABLET in 1 BOTTLE, PLASTIC (68788-8401-8) 28 tablet2023-03-21NoNoHistorical
68788-8401-96878884010990 TABLET in 1 BOTTLE, PLASTIC (68788-8401-9) 90 tablet2023-03-21NoNoHistorical