FDA.reportPublic FDA data

Clonazepam

Product NDC
16729-136
11-digit product format
167290136
Labeler code
16729
Product ID
16729-136_0e1e7f41-f78b-27cf-e063-6394a90a1ae0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA077147
Marketing category
ANDA
Marketing start
2011-06-03
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, 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
16729-136-00Clonazepam100 in 1 BOTTLE, PLASTICTABLET1009
16729-136-16Clonazepam500 in 1 BOTTLE, PLASTICTABLET5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-136-00EA - Each16729-13650a69da8-ec12-4589-91c6-bb770517066e12012-07-24
16729-136-16EA - Each16729-13653ac3278-094b-4def-bf80-dbace3e5f96612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONAZEPAMACTIVE INGREDIENT5PE9FDE8GBCLONAZEPAM TABLET [TYA PHARMACEUTICALS]2
CLONAZEPAMACTIVE INGREDIENT5PE9FDE8GBCLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]2
CLONAZEPAMACTIVE MOIETY5PE9FDE8GBCLONAZEPAM TABLET [TYA PHARMACEUTICALS]2
CLONAZEPAMACTIVE MOIETY5PE9FDE8GBCLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCLONAZEPAM TABLET [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLONAZEPAM TABLET [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CLONAZEPAM TABLET [TYA PHARMACEUTICALS]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONAZEPAM TABLET [TYA PHARMACEUTICALS]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONAZEPAM TABLET [TYA PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONAZEPAM TABLET [TYA PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-136CLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]9Current NDC, Legacy NDC, 2 package rows20240105_ebc11109-e7bf-452d-b675-4b3236d54164.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197527clonazePAM 0.5 MG Oral TabletPSN213c0120-507c-4c39-8aa4-3377f0b06d74102
197527clonazepam 0.5 MG Oral TabletSCD213c0120-507c-4c39-8aa4-3377f0b06d74102
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
197527clonazePAM 0.5 MG Oral TabletPSNc707caa1-d6fd-4790-9a64-f749bf93ef1817
197527clonazepam 0.5 MG Oral TabletSCDc707caa1-d6fd-4790-9a64-f749bf93ef1817
197527clonazePAM 0.5 MG Oral TabletPSN3aa9c3eb-3a0a-4e8b-af68-4f87d87194dd11
197527clonazepam 0.5 MG Oral TabletSCD3aa9c3eb-3a0a-4e8b-af68-4f87d87194dd11
197527clonazePAM 0.5 MG Oral TabletPSNebc11109-e7bf-452d-b675-4b3236d541649
197528clonazePAM 1 MG Oral TabletPSNebc11109-e7bf-452d-b675-4b3236d541649
197529clonazePAM 2 MG Oral TabletPSNebc11109-e7bf-452d-b675-4b3236d541649
197527clonazepam 0.5 MG Oral TabletSCDebc11109-e7bf-452d-b675-4b3236d541649
197528clonazepam 1 MG Oral TabletSCDebc11109-e7bf-452d-b675-4b3236d541649
197529clonazepam 2 MG Oral TabletSCDebc11109-e7bf-452d-b675-4b3236d541649
197527clonazePAM 0.5 MG Oral TabletPSN00f323c0-e007-40df-ae7f-e6b3c7ba0aa88
197527clonazePAM 0.5 MG Oral TabletPSNb9309a1a-a794-2f62-e053-2a95a90a7c348
197527clonazepam 0.5 MG Oral TabletSCDb9309a1a-a794-2f62-e053-2a95a90a7c348
197527clonazepam 0.5 MG Oral TabletSCD00f323c0-e007-40df-ae7f-e6b3c7ba0aa88
197527clonazePAM 0.5 MG Oral TabletPSN555061d4-276a-4716-e054-00144ff88e886
197527clonazepam 0.5 MG Oral TabletSCD555061d4-276a-4716-e054-00144ff88e886
197527clonazePAM 0.5 MG Oral TabletPSN4dcb6785-e16b-4692-89b3-f905979ca5ae5
197527clonazepam 0.5 MG Oral TabletSCD4dcb6785-e16b-4692-89b3-f905979ca5ae5
197527clonazePAM 0.5 MG Oral TabletPSN7e07c99c-5bf4-4310-8d5c-be219dce194d4
197527clonazepam 0.5 MG Oral TabletSCD7e07c99c-5bf4-4310-8d5c-be219dce194d4
197527clonazePAM 0.5 MG Oral TabletPSN7f7a5a78-ec40-428c-a922-24166dc74cdb3
197527clonazepam 0.5 MG Oral TabletSCD7f7a5a78-ec40-428c-a922-24166dc74cdb3
197527clonazePAM 0.5 MG Oral TabletPSN04db8e8c-38f9-0c4a-e063-6394a90a93f02
197527clonazePAM 0.5 MG Oral TabletPSN33ddcf8d-0515-4d05-bcb4-a5690fbf40fd2
197527clonazePAM 0.5 MG Oral TabletPSN7b0d716c-8f51-47a7-8bf2-07c6f9732a052
197527clonazepam 0.5 MG Oral TabletSCD04db8e8c-38f9-0c4a-e063-6394a90a93f02
197527clonazepam 0.5 MG Oral TabletSCD7b0d716c-8f51-47a7-8bf2-07c6f9732a052
197527clonazepam 0.5 MG Oral TabletSCD33ddcf8d-0515-4d05-bcb4-a5690fbf40fd2
197527clonazePAM 0.5 MG Oral TabletPSN58af8964-3480-2139-e053-2991aa0a06241
197527clonazePAM 0.5 MG Oral TabletPSNc217de42-4d9c-4b00-9acf-83609813626b1
197528clonazePAM 1 MG Oral TabletPSN58af8964-3480-2139-e053-2991aa0a06241
197529clonazePAM 2 MG Oral TabletPSN58af8964-3480-2139-e053-2991aa0a06241
197527clonazepam 0.5 MG Oral TabletSCDc217de42-4d9c-4b00-9acf-83609813626b1
197527clonazepam 0.5 MG Oral TabletSCD58af8964-3480-2139-e053-2991aa0a06241
197528clonazepam 1 MG Oral TabletSCD58af8964-3480-2139-e053-2991aa0a06241
197529clonazepam 2 MG Oral TabletSCD58af8964-3480-2139-e053-2991aa0a06241

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-136-0016729013600100 TABLET in 1 BOTTLE, PLASTIC (16729-136-00) 100 tablet2011-06-030000-00-00NoNoCurrent
16729-136-1616729013616500 TABLET in 1 BOTTLE, PLASTIC (16729-136-16) 500 tablet2011-06-030000-00-00NoNoCurrent