methylphenidate hydrochloride

Generic: methylphenidate hydrochloride

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

Drug Facts

Product Profile

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

methylphenidate hydrochloride 10 mg/1

Manufacturer
Nivagen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 75834-325
Product ID 75834-325_4cc16009-44ad-4055-ac76-efa282f1ff47
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208737
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2024-04-16

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 75834325
Hyphenated Format 75834-325

Supplemental Identifiers

RxCUI
1091150 1091392 1091497
UNII
4B3SC438HI

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 methylphenidate hydrochloride (source: ndc)
Generic Name methylphenidate hydrochloride (source: ndc)
Application Number ANDA208737 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (75834-325-01)
source: ndc

Packages (1)

75834-325-01 100 TABLET in 1 BOTTLE (75834-325-01)

Ingredients (1)

methylphenidate hydrochloride (10 mg/1)

Linked Drug Pages (1)

METHYLPHENIDATE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4cc16009-44ad-4055-ac76-efa282f1ff47", "openfda": {"unii": ["4B3SC438HI"], "rxcui": ["1091150", "1091392", "1091497"], "spl_set_id": ["4cc16009-44ad-4055-ac76-efa282f1ff47"], "manufacturer_name": ["Nivagen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (75834-325-01)", "package_ndc": "75834-325-01", "marketing_start_date": "20240416"}], "brand_name": "METHYLPHENIDATE HYDROCHLORIDE", "product_id": "75834-325_4cc16009-44ad-4055-ac76-efa282f1ff47", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "75834-325", "dea_schedule": "CII", "generic_name": "METHYLPHENIDATE HYDROCHLORIDE", "labeler_name": "Nivagen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METHYLPHENIDATE HYDROCHLORIDE", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA208737", "marketing_category": "ANDA", "marketing_start_date": "20240416", "listing_expiration_date": "20261231"}