methylphenidate

Generic: methylphenidate

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name methylphenidate
Generic Name methylphenidate
Labeler sandoz inc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 30 mg/1

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-2385
Product ID 0781-2385_ade65b90-a3e4-4df4-a066-b72f161dc306
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021284
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2015-11-24

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 07812385
Hyphenated Format 0781-2385

Supplemental Identifiers

RxCUI
1806177 1806179 1806183 1806195
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 (source: ndc)
Generic Name methylphenidate (source: ndc)
Application Number NDA021284 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2385-01)
source: ndc

Packages (1)

0781-2385-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2385-01)

Ingredients (1)

methylphenidate hydrochloride (30 mg/1)

Linked Drug Pages (1)

Methylphenidate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ade65b90-a3e4-4df4-a066-b72f161dc306", "openfda": {"unii": ["4B3SC438HI"], "rxcui": ["1806177", "1806179", "1806183", "1806195"], "spl_set_id": ["44386394-d2a3-4483-abe1-6c5c634cc501"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2385-01)", "package_ndc": "0781-2385-01", "marketing_start_date": "20250610"}], "brand_name": "Methylphenidate", "product_id": "0781-2385_ade65b90-a3e4-4df4-a066-b72f161dc306", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0781-2385", "dea_schedule": "CII", "generic_name": "methylphenidate", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylphenidate", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "NDA021284", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20151124", "listing_expiration_date": "20261231"}