dexmethylphenidate hydrochloride

Generic: dexmethylphenidate hydrochloride

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexmethylphenidate hydrochloride
Generic Name dexmethylphenidate hydrochloride
Labeler amneal pharmaceuticals of new york llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

dexmethylphenidate hydrochloride 20 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-1685
Product ID 0115-1685_d431fe33-4a29-4d90-9d0d-38f146aedbd6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079108
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2015-12-21

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 01151685
Hyphenated Format 0115-1685

Supplemental Identifiers

RxCUI
899439 899461 899485 899495 899511
UPC
0301151683013 0301151686014 0301151682016 0301151684010 0301151685017
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 ANDA079108 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0115-1685-01)
source: ndc

Packages (1)

0115-1685-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0115-1685-01)

Ingredients (1)

dexmethylphenidate hydrochloride (20 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": "d431fe33-4a29-4d90-9d0d-38f146aedbd6", "openfda": {"upc": ["0301151683013", "0301151686014", "0301151682016", "0301151684010", "0301151685017"], "unii": ["1678OK0E08"], "rxcui": ["899439", "899461", "899485", "899495", "899511"], "spl_set_id": ["5312f2c3-bd73-4d29-b8d1-e989282be750"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0115-1685-01)", "package_ndc": "0115-1685-01", "marketing_start_date": "20151221"}], "brand_name": "Dexmethylphenidate hydrochloride", "product_id": "0115-1685_d431fe33-4a29-4d90-9d0d-38f146aedbd6", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0115-1685", "dea_schedule": "CII", "generic_name": "Dexmethylphenidate hydrochloride", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmethylphenidate hydrochloride", "active_ingredients": [{"name": "DEXMETHYLPHENIDATE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA079108", "marketing_category": "ANDA", "marketing_start_date": "20151221", "listing_expiration_date": "20261231"}