methylphenidate hydrochloride

Generic: methylphenidate hydrochloride

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

Drug Facts

Product Profile

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

methylphenidate hydrochloride 20 mg/1

Manufacturer
Granules Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 70010-043
Product ID 70010-043_411818b5-dc2c-93c3-e063-6294a90a7638
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210992
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2018-12-17

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 70010043
Hyphenated Format 70010-043

Supplemental Identifiers

RxCUI
1091145 1091225
UPC
0370010043039 0370010042032
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 ANDA210992 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70010-043-01)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70010-043-03)
source: ndc

Packages (2)

70010-043-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70010-043-01) 70010-043-03 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70010-043-03)

Ingredients (1)

methylphenidate hydrochloride (20 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": "411818b5-dc2c-93c3-e063-6294a90a7638", "openfda": {"upc": ["0370010043039", "0370010042032"], "unii": ["4B3SC438HI"], "rxcui": ["1091145", "1091225"], "spl_set_id": ["45d33807-88b2-4b42-9c86-e5b05d7adec1"], "manufacturer_name": ["Granules Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70010-043-01)", "package_ndc": "70010-043-01", "marketing_start_date": "20181217"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70010-043-03)", "package_ndc": "70010-043-03", "marketing_start_date": "20221031"}], "brand_name": "METHYLPHENIDATE HYDROCHLORIDE", "product_id": "70010-043_411818b5-dc2c-93c3-e063-6294a90a7638", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "70010-043", "dea_schedule": "CII", "generic_name": "METHYLPHENIDATE HYDROCHLORIDE", "labeler_name": "Granules Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METHYLPHENIDATE HYDROCHLORIDE", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA210992", "marketing_category": "ANDA", "marketing_start_date": "20181217", "listing_expiration_date": "20261231"}