FDA.reportPublic FDA data

NDC 21695-261-00 - Clonazepam

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
21695-261
Requested NDC
21695-261-00
Package NDCs from labels
21695-261-30, 21695-261-60, 21695-261-90, 21695-261-00, 21695-261-72
Manufacturer
Rebel Distributors
Effective date
2009-09-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Clonazepam - Rebel DistributorsRebel Distributors2009-09-01HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
21695-261-30CLONAZEPAM TABLETS, USP CIV 0832 0833 0834 Rx only
21695-261-60CLONAZEPAM TABLETS, USP CIV 0832 0833 0834 Rx only
21695-261-72CLONAZEPAM TABLETS, USP CIV 0832 0833 0834 Rx only
21695-261-90CLONAZEPAM TABLETS, USP CIV 0832 0833 0834 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-261-00Clonazepam100 in 1 BOTTLETABLET1001
21695-261-30Clonazepam30 in 1 BOTTLETABLET301
21695-261-60Clonazepam60 in 1 BOTTLETABLET601
21695-261-72Clonazepam120 in 1 BOTTLETABLET1201
21695-261-90Clonazepam90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-261CLONAZEPAM TABLET [REBEL DISTRIBUTORS]1Legacy NDC, 5 package rows20091229_f78213e2-c758-4a1d-810f-f9b2c2c35ecc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-261-00EA - Each21695-26142bbb7bd-1ee1-483e-9752-c84a9ff797b212012-07-24
21695-261-30EA - Each21695-261ec5ddf4b-237d-400f-ae9c-6a2ad7cf99b312012-07-24
21695-261-60EA - Each21695-2610eace733-8714-4fdb-a4ff-a90c265c252512012-07-24
21695-261-72EA - Each21695-2616dc79e6e-ee0e-4f1b-a273-e96eb524675112012-07-24
21695-261-90EA - Each21695-2611284f72f-3c43-4b70-9be3-ff1b7073a3b712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONAZEPAMACTIVE INGREDIENT5PE9FDE8GBCLONAZEPAM TABLET [REBEL DISTRIBUTORS]1
CLONAZEPAMACTIVE MOIETY5PE9FDE8GBCLONAZEPAM TABLET [REBEL DISTRIBUTORS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLONAZEPAM TABLET [REBEL DISTRIBUTORS]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLONAZEPAM TABLET [REBEL DISTRIBUTORS]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCLONAZEPAM TABLET [REBEL DISTRIBUTORS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONAZEPAM TABLET [REBEL DISTRIBUTORS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONAZEPAM TABLET [REBEL DISTRIBUTORS]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ECLONAZEPAM TABLET [REBEL DISTRIBUTORS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONAZEPAM TABLET [REBEL DISTRIBUTORS]1
WATERINACTIVE INGREDIENT059QF0KO0RCLONAZEPAM TABLET [REBEL DISTRIBUTORS]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 17 · 325 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
ClonazepamCLONAZEPAMREMEDYREPACK INC.2606ecf9-3d71-4c1c-bfda-d7d98ffc60112026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
unii: 5PE9FDE8GB
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
ClonazepamCLONAZEPAMREMEDYREPACK INC.9c3b1b37-8bc0-427a-8c7a-14da7bd49a7f2026-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197527
unii: 5PE9FDE8GB
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ClonazepamCLONAZEPAMREMEDYREPACK INC.64bb2cdf-f57d-4a41-a5bf-ee77b6e64d062026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074569
rxcui: 197528
unii: 5PE9FDE8GB
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ClonazepamCLONAZEPAMBryant Ranch Prepack19475112-60da-4d53-b330-70afe28ebaf32026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197529
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMBryant Ranch Prepackc4b87c17-efcd-4b66-96e7-159a04c808b52026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197527
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMBryant Ranch Prepack8bb69bbe-07e1-4123-9b70-fde78d1d0a342026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMREMEDYREPACK INC.874b0395-fecb-446a-966f-6ecbb23f1ff62026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
unii: 5PE9FDE8GB

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.