FDA.reportPublic FDA data

Clonazepam

Product NDC
16729-137
11-digit product format
167290137
Labeler code
16729
Product ID
16729-137_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
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
16729-137-00Clonazepam100 in 1 BOTTLE, PLASTICTABLET1009
16729-137-16Clonazepam500 in 1 BOTTLE, PLASTICTABLET5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-137-00EA - Each16729-137dd0260df-51d1-4d40-b009-6d0c71861ea412012-07-24
16729-137-16EA - Each16729-137a473b6c6-5710-4f7f-b17c-2294d3f64e2d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONAZEPAMACTIVE INGREDIENT5PE9FDE8GBCLONAZEPAM TABLET [DIRECT RX]2
CLONAZEPAMACTIVE INGREDIENT5PE9FDE8GBCLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]2
CLONAZEPAMACTIVE MOIETY5PE9FDE8GBCLONAZEPAM TABLET [DIRECT RX]2
CLONAZEPAMACTIVE MOIETY5PE9FDE8GBCLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLONAZEPAM TABLET [DIRECT RX]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 [ACCORD HEALTHCARE INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONAZEPAM TABLET [DIRECT RX]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONAZEPAM TABLET [DIRECT RX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONAZEPAM TABLET [DIRECT RX]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-137CLONAZEPAM 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 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
197528clonazePAM 1 MG Oral TabletPSN4b5240a8-9e87-4664-8698-596a144d6d2817
197528clonazepam 1 MG Oral TabletSCD4b5240a8-9e87-4664-8698-596a144d6d2817
197528clonazePAM 1 MG Oral TabletPSN9ee4e019-6a99-4aac-84b0-9aae597815a716
197528clonazepam 1 MG Oral TabletSCD9ee4e019-6a99-4aac-84b0-9aae597815a716
197528clonazePAM 1 MG Oral TabletPSN31a7ed52-48a6-1c87-e054-00144ff88e8815
197528clonazePAM 1 MG Oral TabletPSN874b0395-fecb-446a-966f-6ecbb23f1ff615
197528clonazepam 1 MG Oral TabletSCD874b0395-fecb-446a-966f-6ecbb23f1ff615
197528clonazepam 1 MG Oral TabletSCD31a7ed52-48a6-1c87-e054-00144ff88e8815
197528clonazePAM 1 MG Oral TabletPSNa4185456-68f9-47d4-9952-fcdef86989db11
197528clonazepam 1 MG Oral TabletSCDa4185456-68f9-47d4-9952-fcdef86989db11
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
197528clonazePAM 1 MG Oral TabletPSNbe383e56-d71f-7699-e053-2995a90a50c18
197528clonazepam 1 MG Oral TabletSCDbe383e56-d71f-7699-e053-2995a90a50c18
197528clonazePAM 1 MG Oral TabletPSN78f87e87-6d36-4ee8-9d2d-ec75666c71ce7
197528clonazepam 1 MG Oral TabletSCD78f87e87-6d36-4ee8-9d2d-ec75666c71ce7
197528clonazePAM 1 MG Oral TabletPSNd65c9a1e-f2f4-46d2-9b28-ba0e5c67e5425
197528clonazepam 1 MG Oral TabletSCDd65c9a1e-f2f4-46d2-9b28-ba0e5c67e5425
197528clonazePAM 1 MG Oral TabletPSNa4882077-694d-d46c-e053-2a95a90a217d3
197528clonazepam 1 MG Oral TabletSCDa4882077-694d-d46c-e053-2a95a90a217d3
197528clonazePAM 1 MG Oral TabletPSN3ca76628-96c5-4fda-a4ee-eeafbcf90a072
197529clonazePAM 2 MG Oral TabletPSN3ca76628-96c5-4fda-a4ee-eeafbcf90a072
197528clonazepam 1 MG Oral TabletSCD3ca76628-96c5-4fda-a4ee-eeafbcf90a072
197529clonazepam 2 MG Oral TabletSCD3ca76628-96c5-4fda-a4ee-eeafbcf90a072
197527clonazePAM 0.5 MG Oral TabletPSN58af8964-3480-2139-e053-2991aa0a06241
197528clonazePAM 1 MG Oral TabletPSN58af8964-3480-2139-e053-2991aa0a06241
197528clonazePAM 1 MG Oral TabletPSN8d6e2f75-be76-db92-e053-2995a90ae4061
197528clonazePAM 1 MG Oral TabletPSNc68420a9-b646-4a4f-99f7-43d652312eb01
197528clonazePAM 1 MG Oral TabletPSN8d6ddd91-0397-a23b-e053-2a95a90abc831
197529clonazePAM 2 MG Oral TabletPSN58af8964-3480-2139-e053-2991aa0a06241
197527clonazepam 0.5 MG Oral TabletSCD58af8964-3480-2139-e053-2991aa0a06241
197528clonazepam 1 MG Oral TabletSCD8d6ddd91-0397-a23b-e053-2a95a90abc831
197528clonazepam 1 MG Oral TabletSCD8d6e2f75-be76-db92-e053-2995a90ae4061
197528clonazepam 1 MG Oral TabletSCDc68420a9-b646-4a4f-99f7-43d652312eb01
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
16729-137-0016729013700100 TABLET in 1 BOTTLE, PLASTIC (16729-137-00) 100 tablet2011-06-030000-00-00NoNoCurrent
16729-137-1616729013716500 TABLET in 1 BOTTLE, PLASTIC (16729-137-16) 500 tablet2011-06-030000-00-00NoNoCurrent