FDA.reportPublic FDA data

Clonazepam

Product NDC
43547-407
11-digit product format
435470407
Labeler code
43547
Product ID
43547-407_dc17b9d4-2890-4f6c-8476-daa39d0cbc9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare LLC
Application
ANDA077856
Marketing category
ANDA
Marketing start
2018-02-15
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-407-10Clonazepam100 in 1 BOTTLE, PLASTICTABLET1009
43547-407-11Clonazepam1000 in 1 BOTTLE, PLASTICTABLET10009
43547-407-50Clonazepam500 in 1 BOTTLE, PLASTICTABLET5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-407-10EA - Each43547-4072a99980c-7163-47f2-aac0-c5108c834b9912018-03-08
43547-407-11EA - Each43547-40710200076-573b-4f3c-89f2-b4d8f431bea012018-03-08
43547-407-50EA - Each43547-4070f9ea6ad-20b1-4cdb-8c4e-5dfaca9daae712018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-407CLONAZEPAM TABLET [SOLCO HEALTHCARE LLC]7Current NDC, Legacy NDC, 3 package rows20230506_4acbb7a9-4db5-4497-b8db-9f358b3f6fb4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197528clonazePAM 1 MG Oral TabletPSN5ae98718-9da5-4edc-8efb-67b212577548103
197528clonazePAM 1 MG Oral TabletPSNb83009c2-26ed-45fa-819e-164cdac264e6103
197528clonazepam 1 MG Oral TabletSCD5ae98718-9da5-4edc-8efb-67b212577548103
197528clonazepam 1 MG Oral TabletSCDb83009c2-26ed-45fa-819e-164cdac264e6103
197528clonazePAM 1 MG Oral TabletPSNee7f0165-91fe-4faa-9ee2-1fcac4ffd265102
197528clonazepam 1 MG Oral TabletSCDee7f0165-91fe-4faa-9ee2-1fcac4ffd265102
197528clonazePAM 1 MG Oral TabletPSN5ec3df57-1137-4402-84e6-28dd76286427101
197528clonazepam 1 MG Oral TabletSCD5ec3df57-1137-4402-84e6-28dd76286427101
197527clonazePAM 0.5 MG Oral TabletPSN4acbb7a9-4db5-4497-b8db-9f358b3f6fb49
197528clonazePAM 1 MG Oral TabletPSNca79f244-7e6e-4612-af26-e6e5cefbd3a29
197528clonazePAM 1 MG Oral TabletPSN4acbb7a9-4db5-4497-b8db-9f358b3f6fb49
197529clonazePAM 2 MG Oral TabletPSN4acbb7a9-4db5-4497-b8db-9f358b3f6fb49
197527clonazepam 0.5 MG Oral TabletSCD4acbb7a9-4db5-4497-b8db-9f358b3f6fb49
197528clonazepam 1 MG Oral TabletSCD4acbb7a9-4db5-4497-b8db-9f358b3f6fb49
197528clonazepam 1 MG Oral TabletSCDca79f244-7e6e-4612-af26-e6e5cefbd3a29
197529clonazepam 2 MG Oral TabletSCD4acbb7a9-4db5-4497-b8db-9f358b3f6fb49
197527clonazePAM 0.5 MG Oral TabletPSN34366dd2-432c-4fa9-8fab-832cca781b846
197528clonazePAM 1 MG Oral TabletPSN254a03c9-070c-40e6-83ac-524c1aec3b6b6
197528clonazePAM 1 MG Oral TabletPSN34366dd2-432c-4fa9-8fab-832cca781b846
197527clonazepam 0.5 MG Oral TabletSCD34366dd2-432c-4fa9-8fab-832cca781b846
197528clonazepam 1 MG Oral TabletSCD254a03c9-070c-40e6-83ac-524c1aec3b6b6
197528clonazepam 1 MG Oral TabletSCD34366dd2-432c-4fa9-8fab-832cca781b846
197528clonazePAM 1 MG Oral TabletPSN87f362a7-cf66-4166-af51-ac2da473cf6b4
197528clonazepam 1 MG Oral TabletSCD87f362a7-cf66-4166-af51-ac2da473cf6b4
197527clonazePAM 0.5 MG Oral TabletPSNf2662808-01c4-330c-e053-2a95a90aa3353
197527clonazePAM 0.5 MG Oral TabletPSNc13297e2-ae3e-4198-b7c8-55fd672436aa3
197528clonazePAM 1 MG Oral TabletPSNf2662808-01c4-330c-e053-2a95a90aa3353
197528clonazePAM 1 MG Oral TabletPSNc13297e2-ae3e-4198-b7c8-55fd672436aa3
197529clonazePAM 2 MG Oral TabletPSNf2662808-01c4-330c-e053-2a95a90aa3353
197527clonazepam 0.5 MG Oral TabletSCDf2662808-01c4-330c-e053-2a95a90aa3353
197527clonazepam 0.5 MG Oral TabletSCDc13297e2-ae3e-4198-b7c8-55fd672436aa3
197528clonazepam 1 MG Oral TabletSCDc13297e2-ae3e-4198-b7c8-55fd672436aa3
197528clonazepam 1 MG Oral TabletSCDf2662808-01c4-330c-e053-2a95a90aa3353
197529clonazepam 2 MG Oral TabletSCDf2662808-01c4-330c-e053-2a95a90aa3353
197528clonazePAM 1 MG Oral TabletPSNfc75869c-cd6b-44a3-e053-6294a90a699e2
197528clonazePAM 1 MG Oral TabletPSN2cb46dc0-a03e-42d7-ba67-22319598389f2
197528clonazepam 1 MG Oral TabletSCDfc75869c-cd6b-44a3-e053-6294a90a699e2
197528clonazepam 1 MG Oral TabletSCD2cb46dc0-a03e-42d7-ba67-22319598389f2
197528clonazePAM 1 MG Oral TabletPSN63286201-4b79-45b8-8f48-7e21dadc14081
197528clonazePAM 1 MG Oral TabletPSN511216c7-6878-f90a-e063-6394a90aaac81
197528clonazePAM 1 MG Oral TabletPSN37666d94-0898-4656-9c08-f6d1f54914061
197528clonazePAM 1 MG Oral TabletPSNf7f968c9-e661-e32c-e053-6294a90afbc01
197528clonazepam 1 MG Oral TabletSCD63286201-4b79-45b8-8f48-7e21dadc14081
197528clonazepam 1 MG Oral TabletSCD511216c7-6878-f90a-e063-6394a90aaac81
197528clonazepam 1 MG Oral TabletSCD37666d94-0898-4656-9c08-f6d1f54914061
197528clonazepam 1 MG Oral TabletSCDf7f968c9-e661-e32c-e053-6294a90afbc01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-407-1043547040710100 TABLET in 1 BOTTLE, PLASTIC (43547-407-10) 100 tablet2018-02-150000-00-00NoNoCurrent
43547-407-11435470407111000 TABLET in 1 BOTTLE, PLASTIC (43547-407-11) 1000 tablet2018-02-150000-00-00NoNoCurrent
43547-407-5043547040750500 TABLET in 1 BOTTLE, PLASTIC (43547-407-50) 500 tablet2018-02-150000-00-00NoNoCurrent