methylphenidate hydrochloride

Generic: methylphenidate hydrochloride

Labeler: accord healthcare, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylphenidate hydrochloride
Generic Name methylphenidate hydrochloride
Labeler accord healthcare, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 10 mg/1

Manufacturer
Accord Healthcare, Inc.

Identifiers & Regulatory

Product NDC 16729-479
Product ID 16729-479_1b2d1579-1bb4-cc17-e063-6294a90a4fa7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213936
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2020-12-17

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 16729479
Hyphenated Format 16729-479

Supplemental Identifiers

RxCUI
1091150 1091392 1091497
UPC
0316729479011 0316729480017 0316729478014
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 ANDA213936 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (16729-479-01)
source: ndc

Packages (1)

16729-479-01 100 TABLET in 1 BOTTLE (16729-479-01)

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": "1b2d1579-1bb4-cc17-e063-6294a90a4fa7", "openfda": {"upc": ["0316729479011", "0316729480017", "0316729478014"], "unii": ["4B3SC438HI"], "rxcui": ["1091150", "1091392", "1091497"], "spl_set_id": ["4f3c91e6-4576-4326-bdab-7d8fb7c09bb8"], "manufacturer_name": ["Accord Healthcare, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (16729-479-01)", "package_ndc": "16729-479-01", "marketing_start_date": "20201217"}], "brand_name": "METHYLPHENIDATE HYDROCHLORIDE", "product_id": "16729-479_1b2d1579-1bb4-cc17-e063-6294a90a4fa7", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "16729-479", "dea_schedule": "CII", "generic_name": "METHYLPHENIDATE HYDROCHLORIDE", "labeler_name": "Accord Healthcare, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METHYLPHENIDATE HYDROCHLORIDE", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA213936", "marketing_category": "ANDA", "marketing_start_date": "20201217", "listing_expiration_date": "20261231"}