dexmethylphenidate hydrochloride

Generic: dexmethylphenidate hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexmethylphenidate hydrochloride
Generic Name dexmethylphenidate hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dexmethylphenidate hydrochloride 5 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 57664-378
Product ID 57664-378_0d0cbfc3-ae27-b481-e063-6394a90a917c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201231
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2013-09-26

Pharmacologic Class

Classes
central nervous system stimulant [epc] central nervous system stimulation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57664378
Hyphenated Format 57664-378

Supplemental Identifiers

RxCUI
899518 899548 899557
UNII
1678OK0E08

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 dexmethylphenidate hydrochloride (source: ndc)
Generic Name dexmethylphenidate hydrochloride (source: ndc)
Application Number ANDA201231 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (57664-378-08)
  • 500 TABLET in 1 BOTTLE (57664-378-13)
  • 1000 TABLET in 1 BOTTLE (57664-378-18)
  • 30 TABLET in 1 BOTTLE (57664-378-83)
  • 100 TABLET in 1 BOTTLE (57664-378-88)
source: ndc

Packages (5)

57664-378-08 100 TABLET in 1 BOTTLE (57664-378-08) 57664-378-13 500 TABLET in 1 BOTTLE (57664-378-13) 57664-378-18 1000 TABLET in 1 BOTTLE (57664-378-18) 57664-378-83 30 TABLET in 1 BOTTLE (57664-378-83) 57664-378-88 100 TABLET in 1 BOTTLE (57664-378-88)

Ingredients (1)

dexmethylphenidate hydrochloride (5 mg/1)

Linked Drug Pages (1)

Dexmethylphenidate hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0d0cbfc3-ae27-b481-e063-6394a90a917c", "openfda": {"unii": ["1678OK0E08"], "rxcui": ["899518", "899548", "899557"], "spl_set_id": ["987b4983-1edc-40f1-adc9-724747080969"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (57664-378-08)", "package_ndc": "57664-378-08", "marketing_start_date": "20130926"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (57664-378-13)", "package_ndc": "57664-378-13", "marketing_start_date": "20130926"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (57664-378-18)", "package_ndc": "57664-378-18", "marketing_start_date": "20130926"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (57664-378-83)", "package_ndc": "57664-378-83", "marketing_start_date": "20130926"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (57664-378-88)", "package_ndc": "57664-378-88", "marketing_start_date": "20130926"}], "brand_name": "Dexmethylphenidate hydrochloride", "product_id": "57664-378_0d0cbfc3-ae27-b481-e063-6394a90a917c", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "57664-378", "dea_schedule": "CII", "generic_name": "Dexmethylphenidate hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmethylphenidate hydrochloride", "active_ingredients": [{"name": "DEXMETHYLPHENIDATE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA201231", "marketing_category": "ANDA", "marketing_start_date": "20130926", "listing_expiration_date": "20261231"}