methylphenidate hydrochloride

Generic: methylphenidate hydrochloride

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylphenidate hydrochloride
Generic Name methylphenidate hydrochloride
Labeler avpak
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 10 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-528
Product ID 50268-528_47e73f94-511d-3879-e063-6394a90ab6af
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207416
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2020-07-10

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 50268528
Hyphenated Format 50268-528

Supplemental Identifiers

RxCUI
1091150 1091392
UNII
4B3SC438HI

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 ANDA207416 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-528-15) / 1 TABLET in 1 BLISTER PACK (50268-528-11)
source: ndc

Packages (1)

50268-528-15 50 BLISTER PACK in 1 BOX (50268-528-15) / 1 TABLET in 1 BLISTER PACK (50268-528-11)

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": "47e73f94-511d-3879-e063-6394a90ab6af", "openfda": {"unii": ["4B3SC438HI"], "rxcui": ["1091150", "1091392"], "spl_set_id": ["9e7967c8-d323-160d-e053-2995a90a323e"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-528-15)  / 1 TABLET in 1 BLISTER PACK (50268-528-11)", "package_ndc": "50268-528-15", "marketing_start_date": "20200710"}], "brand_name": "METHYLPHENIDATE HYDROCHLORIDE", "product_id": "50268-528_47e73f94-511d-3879-e063-6394a90ab6af", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "50268-528", "dea_schedule": "CII", "generic_name": "METHYLPHENIDATE HYDROCHLORIDE", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METHYLPHENIDATE HYDROCHLORIDE", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA207416", "marketing_category": "ANDA", "marketing_start_date": "20200710", "listing_expiration_date": "20271231"}