methylphenidate hydrochloride

Generic: methylphenidate hydrochloride

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

Drug Facts

Product Profile

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

methylphenidate hydrochloride 27 mg/1

Manufacturer
XLCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72865-134
Product ID 72865-134_f0d4af9c-1d16-4405-ac11-6c412af320eb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211009
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2020-02-24

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 72865134
Hyphenated Format 72865-134

Supplemental Identifiers

RxCUI
1091155 1091170 1091185 1091210
UPC
0372865133019 0372865135013 0372865136010 0372865134016
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 ANDA211009 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 27 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72865-134-01)
source: ndc

Packages (1)

72865-134-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72865-134-01)

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": "f0d4af9c-1d16-4405-ac11-6c412af320eb", "openfda": {"upc": ["0372865133019", "0372865135013", "0372865136010", "0372865134016"], "unii": ["4B3SC438HI"], "rxcui": ["1091155", "1091170", "1091185", "1091210"], "spl_set_id": ["b07150db-fd99-4400-bb83-b3a7544a917a"], "manufacturer_name": ["XLCare Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72865-134-01)", "package_ndc": "72865-134-01", "marketing_start_date": "20200224"}], "brand_name": "Methylphenidate Hydrochloride", "product_id": "72865-134_f0d4af9c-1d16-4405-ac11-6c412af320eb", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "72865-134", "dea_schedule": "CII", "generic_name": "Methylphenidate Hydrochloride", "labeler_name": "XLCare Pharmaceuticals, Inc.", "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": "20200224", "listing_expiration_date": "20261231"}