methylphenidate hydrochloride

Generic: methylphenidate hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylphenidate hydrochloride
Generic Name methylphenidate hydrochloride
Labeler bryant ranch prepack
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 27 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-2460
Product ID 63629-2460_5de3e4f4-15cc-41e7-a701-7a084836aeee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205327
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2017-08-14

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 636292460
Hyphenated Format 63629-2460

Supplemental Identifiers

RxCUI
1091170
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 ANDA205327 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 27 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-2460-1)
source: ndc

Packages (1)

Ingredients (1)

methylphenidate hydrochloride (27 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "5de3e4f4-15cc-41e7-a701-7a084836aeee", "openfda": {"unii": ["4B3SC438HI"], "rxcui": ["1091170"], "spl_set_id": ["af3a11ff-8b24-4b48-bcd0-1faff1535985"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-2460-1)", "package_ndc": "63629-2460-1", "marketing_start_date": "20241010"}], "brand_name": "Methylphenidate Hydrochloride", "product_id": "63629-2460_5de3e4f4-15cc-41e7-a701-7a084836aeee", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "63629-2460", "dea_schedule": "CII", "generic_name": "Methylphenidate hydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylphenidate Hydrochloride", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "27 mg/1"}], "application_number": "ANDA205327", "marketing_category": "ANDA", "marketing_start_date": "20170814", "listing_expiration_date": "20261231"}