methylphenidate hydrochloride

Generic: methylphenidate hydrochloride

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylphenidate hydrochloride
Generic Name methylphenidate hydrochloride
Labeler rising pharma holdings, inc.
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 10 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-223
Product ID 64980-223_85d614b0-888e-461f-bc7d-3f240ed8bd0e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205756
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2018-12-18

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 64980223
Hyphenated Format 64980-223

Supplemental Identifiers

RxCUI
1091152 1091322 1091389
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 ANDA205756 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, CHEWABLE in 1 BOTTLE (64980-223-01)
source: ndc

Packages (1)

64980-223-01 100 TABLET, CHEWABLE in 1 BOTTLE (64980-223-01)

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": "85d614b0-888e-461f-bc7d-3f240ed8bd0e", "openfda": {"unii": ["4B3SC438HI"], "rxcui": ["1091152", "1091322", "1091389"], "spl_set_id": ["e5cb0740-813f-4dce-8c29-d7680c66e77c"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, CHEWABLE in 1 BOTTLE (64980-223-01)", "package_ndc": "64980-223-01", "marketing_start_date": "20181218"}], "brand_name": "Methylphenidate Hydrochloride", "product_id": "64980-223_85d614b0-888e-461f-bc7d-3f240ed8bd0e", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "64980-223", "dea_schedule": "CII", "generic_name": "Methylphenidate Hydrochloride", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylphenidate Hydrochloride", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA205756", "marketing_category": "ANDA", "marketing_start_date": "20181218", "listing_expiration_date": "20261231"}