dexmethylphenidate hydrochloride

Generic: dexmethylphenidate hydrochloride

Labeler: nivagen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexmethylphenidate hydrochloride
Generic Name dexmethylphenidate hydrochloride
Labeler nivagen pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dexmethylphenidate hydrochloride 5 mg/1

Manufacturer
Nivagen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 75834-327
Product ID 75834-327_6103914c-da93-4648-9180-e5c439a07bc2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209211
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2024-05-03

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 75834327
Hyphenated Format 75834-327

Supplemental Identifiers

RxCUI
899518 899548
UPC
0375834328010 0375834327013
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 ANDA209211 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (75834-327-01)
source: ndc

Packages (1)

75834-327-01 100 TABLET in 1 BOTTLE (75834-327-01)

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": "6103914c-da93-4648-9180-e5c439a07bc2", "openfda": {"upc": ["0375834328010", "0375834327013"], "unii": ["1678OK0E08"], "rxcui": ["899518", "899548"], "spl_set_id": ["638f614c-bf91-4bf6-876f-bf25fa273bc4"], "manufacturer_name": ["Nivagen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (75834-327-01)", "package_ndc": "75834-327-01", "marketing_start_date": "20240503"}], "brand_name": "Dexmethylphenidate hydrochloride", "product_id": "75834-327_6103914c-da93-4648-9180-e5c439a07bc2", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "75834-327", "dea_schedule": "CII", "generic_name": "Dexmethylphenidate hydrochloride", "labeler_name": "Nivagen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmethylphenidate hydrochloride", "active_ingredients": [{"name": "DEXMETHYLPHENIDATE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA209211", "marketing_category": "ANDA", "marketing_start_date": "20240503", "listing_expiration_date": "20271231"}