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, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 27 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-546
Product ID 50268-546_47e731b7-b64e-317b-e063-6294a90a2c8e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211009
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2021-04-22

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 50268546
Hyphenated Format 50268-546

Supplemental Identifiers

RxCUI
1091155 1091170 1091185 1091210
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 ANDA211009 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 27 mg/1
source: ndc
Packaging
  • 20 BLISTER PACK in 1 BOX (50268-546-12) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-546-11)
source: ndc

Packages (1)

50268-546-12 20 BLISTER PACK in 1 BOX (50268-546-12) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-546-11)

Ingredients (1)

methylphenidate hydrochloride (27 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": "47e731b7-b64e-317b-e063-6294a90a2c8e", "openfda": {"unii": ["4B3SC438HI"], "rxcui": ["1091155", "1091170", "1091185", "1091210"], "spl_set_id": ["c0906610-294d-1320-e053-2995a90ad8fd"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "20 BLISTER PACK in 1 BOX (50268-546-12)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-546-11)", "package_ndc": "50268-546-12", "marketing_start_date": "20210422"}], "brand_name": "Methylphenidate Hydrochloride", "product_id": "50268-546_47e731b7-b64e-317b-e063-6294a90a2c8e", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "50268-546", "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": "27 mg/1"}], "application_number": "ANDA211009", "marketing_category": "ANDA", "marketing_start_date": "20210422", "listing_expiration_date": "20271231"}