Clonazepam

Product NDC
16729-138
11-digit product format
167290138
Labeler code
16729
Product ID
16729-138_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
2 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
CLONAZEPAM2 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
16729-138-00Clonazepam100 in 1 BOTTLE, PLASTICTABLET1009
16729-138-16Clonazepam500 in 1 BOTTLE, PLASTICTABLET5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-138-00EA - Each16729-1381092ec4b-252d-4441-b416-561123b33e1312012-07-24
16729-138-16EA - Each16729-138e81d8cce-f733-4bfb-8c84-407618a377f812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONAZEPAMACTIVE INGREDIENT5PE9FDE8GBCLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]2
CLONAZEPAMACTIVE MOIETY5PE9FDE8GBCLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]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 [ACCORD HEALTHCARE INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-138CLONAZEPAM 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
197529clonazePAM 2 MG Oral TabletPSN9a4d3762-cfeb-4ffb-9c9e-40627cc4df71102
197529clonazepam 2 MG Oral TabletSCD9a4d3762-cfeb-4ffb-9c9e-40627cc4df71102
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
197529clonazePAM 2 MG Oral TabletPSN1ce88d2c-70f7-427b-8787-4afd9ce6f71c15
197529clonazepam 2 MG Oral TabletSCD1ce88d2c-70f7-427b-8787-4afd9ce6f71c15
197529clonazePAM 2 MG Oral TabletPSN095a80b0-09f9-4bd1-b377-5212d7c966ba10
197529clonazepam 2 MG Oral TabletSCD095a80b0-09f9-4bd1-b377-5212d7c966ba10
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
197529clonazePAM 2 MG Oral TabletPSNea4a77d6-d5f2-4e28-a156-5af5b3fbac073
197529clonazepam 2 MG Oral TabletSCDea4a77d6-d5f2-4e28-a156-5af5b3fbac073
197528clonazePAM 1 MG Oral TabletPSN3ca76628-96c5-4fda-a4ee-eeafbcf90a072
197529clonazePAM 2 MG Oral TabletPSN3ca76628-96c5-4fda-a4ee-eeafbcf90a072
197529clonazePAM 2 MG Oral TabletPSNb5f7cfb2-2988-5f00-e053-2a95a90aae6d2
197528clonazepam 1 MG Oral TabletSCD3ca76628-96c5-4fda-a4ee-eeafbcf90a072
197529clonazepam 2 MG Oral TabletSCDb5f7cfb2-2988-5f00-e053-2a95a90aae6d2
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
197529clonazePAM 2 MG Oral TabletPSNea0e79ce-74a1-436c-bac8-f2b80201b5871
197529clonazePAM 2 MG Oral TabletPSN58af8964-3480-2139-e053-2991aa0a06241
197527clonazepam 0.5 MG Oral TabletSCD58af8964-3480-2139-e053-2991aa0a06241
197528clonazepam 1 MG Oral TabletSCD58af8964-3480-2139-e053-2991aa0a06241
197529clonazepam 2 MG Oral TabletSCDea0e79ce-74a1-436c-bac8-f2b80201b5871
197529clonazepam 2 MG Oral TabletSCD58af8964-3480-2139-e053-2991aa0a06241

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-138-0016729013800100 TABLET in 1 BOTTLE, PLASTIC (16729-138-00) 100 tablet2011-06-030000-00-00NoNoCurrent
16729-138-1616729013816500 TABLET in 1 BOTTLE, PLASTIC (16729-138-16) 500 tablet2011-06-030000-00-00NoNoCurrent