FDA.reportPublic FDA data

Clonazepam

Product NDC
50090-2022
11-digit product format
500902022
Labeler code
50090
Product ID
50090-2022_f2f5fa44-5c02-4d7d-89d8-ba24cb337600
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077147
Marketing category
ANDA
Marketing start
2011-06-03
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
Rxcui197527, 197528, 197529

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2022-02023-02-07C16284748780-1f386c64a-35cc-0266-e053-dadaa90a7c1aClonazepam Tablets, USP Rx only
50090-2022-12023-02-07C16284748780-1f386c64a-35cc-0266-e053-dadaa90a7c1aClonazepam Tablets, USP Rx only
50090-2022-22023-02-07C16284748780-1f386c64a-35cc-0266-e053-dadaa90a7c1aClonazepam Tablets, USP Rx only
50090-2022-02023-01-30C16284748780-1f386c64a-35cc-0266-e053-dadaa90a7c1aClonazepam Tablets, USP Rx only
50090-2022-12023-01-30C16284748780-1f386c64a-35cc-0266-e053-dadaa90a7c1aClonazepam Tablets, USP Rx only
50090-2022-22023-01-30C16284748780-1f386c64a-35cc-0266-e053-dadaa90a7c1aClonazepam Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2022-0Clonazepam60 in 1 BOTTLETABLET6027
50090-2022-1Clonazepam30 in 1 BOTTLETABLET3027
50090-2022-2Clonazepam90 in 1 BOTTLETABLET9027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2022-0EA - Each50090-2022eeb6238d-905d-48f6-b097-61aa8941074d12018-12-13
50090-2022-2EA - Each50090-2022083d5508-8460-4f3b-b33d-8e773fc38ffc12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2022CLONAZEPAM TABLET [A-S MEDICATION SOLUTIONS]25Current NDC, Legacy NDC, 3 package rows20250221_28675dd6-b952-4e71-b0a3-b701ad6b6344.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197527clonazePAM 0.5 MG Oral TabletPSN28675dd6-b952-4e71-b0a3-b701ad6b634427
197528clonazePAM 1 MG Oral TabletPSN28675dd6-b952-4e71-b0a3-b701ad6b634427
197529clonazePAM 2 MG Oral TabletPSN28675dd6-b952-4e71-b0a3-b701ad6b634427
197527clonazepam 0.5 MG Oral TabletSCD28675dd6-b952-4e71-b0a3-b701ad6b634427
197528clonazepam 1 MG Oral TabletSCD28675dd6-b952-4e71-b0a3-b701ad6b634427
197529clonazepam 2 MG Oral TabletSCD28675dd6-b952-4e71-b0a3-b701ad6b634427

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2022-05009020220060 TABLET in 1 BOTTLE (50090-2022-0) 60 tablet2015-09-210000-00-00NoNoCurrent
50090-2022-15009020220130 TABLET in 1 BOTTLE (50090-2022-1) 30 tablet2015-09-210000-00-00NoNoCurrent
50090-2022-25009020220290 TABLET in 1 BOTTLE (50090-2022-2) 90 tablet2015-09-210000-00-00NoNoCurrent