methylphenidate hydrochloride

Generic: methylphenidate hydrochloride

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylphenidate hydrochloride
Generic Name methylphenidate hydrochloride
Labeler northstar rx llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 72 mg/1

Manufacturer
Northstar Rx LLC

Identifiers & Regulatory

Product NDC 72603-399
Product ID 72603-399_24936e25-28cd-53ce-e063-6294a90ad99d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217229
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2025-02-01

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 72603399
Hyphenated Format 72603-399

Supplemental Identifiers

RxCUI
1995461
UPC
0372603399011
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 ANDA217229 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 72 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72603-399-01)
source: ndc

Packages (1)

72603-399-01 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72603-399-01)

Ingredients (1)

methylphenidate hydrochloride (72 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": "24936e25-28cd-53ce-e063-6294a90ad99d", "openfda": {"upc": ["0372603399011"], "unii": ["4B3SC438HI"], "rxcui": ["1995461"], "spl_set_id": ["768bf181-d0d8-49e5-9c87-cacbb069e0b2"], "manufacturer_name": ["Northstar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72603-399-01)", "package_ndc": "72603-399-01", "marketing_start_date": "20250201"}], "brand_name": "Methylphenidate Hydrochloride", "product_id": "72603-399_24936e25-28cd-53ce-e063-6294a90ad99d", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "72603-399", "dea_schedule": "CII", "generic_name": "Methylphenidate Hydrochloride", "labeler_name": "Northstar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylphenidate Hydrochloride", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "72 mg/1"}], "application_number": "ANDA217229", "marketing_category": "ANDA", "marketing_start_date": "20250201", "listing_expiration_date": "20261231"}