clonazepam

Generic: clonazepam

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clonazepam
Generic Name clonazepam
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

clonazepam .125 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-364
Product ID 46708-364_e19dd42d-3043-4605-9adf-001741e03942
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211033
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2019-07-01

Pharmacologic Class

Established (EPC)
benzodiazepine [epc]
Chemical Structure
benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708364
Hyphenated Format 46708-364

Supplemental Identifiers

RxCUI
349194 349195 349196 349197 349198
UNII
5PE9FDE8GB
NUI
N0000175694 M0002356

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name clonazepam (source: ndc)
Generic Name clonazepam (source: ndc)
Application Number ANDA211033 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .125 mg/1
source: ndc
Packaging
  • 60 BLISTER PACK in 1 CARTON (46708-364-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
source: ndc

Packages (1)

46708-364-06 60 BLISTER PACK in 1 CARTON (46708-364-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Ingredients (1)

clonazepam (.125 mg/1)

Linked Drug Pages (1)

CLONAZEPAM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e19dd42d-3043-4605-9adf-001741e03942", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["5PE9FDE8GB"], "rxcui": ["349194", "349195", "349196", "349197", "349198"], "spl_set_id": ["43ee20ce-0015-413c-b230-822e390b02f7"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 BLISTER PACK in 1 CARTON (46708-364-06)  / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "46708-364-06", "marketing_start_date": "20190701"}], "brand_name": "CLONAZEPAM", "product_id": "46708-364_e19dd42d-3043-4605-9adf-001741e03942", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "46708-364", "dea_schedule": "CIV", "generic_name": "CLONAZEPAM", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CLONAZEPAM", "active_ingredients": [{"name": "CLONAZEPAM", "strength": ".125 mg/1"}], "application_number": "ANDA211033", "marketing_category": "ANDA", "marketing_start_date": "20190701", "listing_expiration_date": "20261231"}