dexmethylphenidate hydrochloride

Generic: dexmethylphenidate hydrochloride

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

Drug Facts

Product Profile

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

dexmethylphenidate hydrochloride 20 mg/1

Manufacturer
Granules Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 70010-007
Product ID 70010-007_412b7fd8-c12a-36c2-e063-6394a90acae6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213813
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2020-12-01

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 70010007
Hyphenated Format 70010-007

Supplemental Identifiers

RxCUI
899439 899461 899485 899495 899511 1006608 1101926 1101932
UPC
0370010011014 0370010010017 0370010009011 0370010006010 0370010004016 0370010007017 0370010008014 0370010005013
UNII
1678OK0E08

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 dexmethylphenidate hydrochloride (source: ndc)
Generic Name dexmethylphenidate hydrochloride (source: ndc)
Application Number ANDA213813 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-007-01)
source: ndc

Packages (1)

70010-007-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-007-01)

Ingredients (1)

dexmethylphenidate hydrochloride (20 mg/1)

Linked Drug Pages (1)

DEXMETHYLPHENIDATE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "412b7fd8-c12a-36c2-e063-6394a90acae6", "openfda": {"upc": ["0370010011014", "0370010010017", "0370010009011", "0370010006010", "0370010004016", "0370010007017", "0370010008014", "0370010005013"], "unii": ["1678OK0E08"], "rxcui": ["899439", "899461", "899485", "899495", "899511", "1006608", "1101926", "1101932"], "spl_set_id": ["abe6862b-3cf3-4aad-98ea-05a5fb54ebec"], "manufacturer_name": ["Granules Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-007-01)", "package_ndc": "70010-007-01", "marketing_start_date": "20201201"}], "brand_name": "DEXMETHYLPHENIDATE HYDROCHLORIDE", "product_id": "70010-007_412b7fd8-c12a-36c2-e063-6394a90acae6", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "70010-007", "dea_schedule": "CII", "generic_name": "DEXMETHYLPHENIDATE HYDROCHLORIDE", "labeler_name": "Granules Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DEXMETHYLPHENIDATE HYDROCHLORIDE", "active_ingredients": [{"name": "DEXMETHYLPHENIDATE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA213813", "marketing_category": "ANDA", "marketing_start_date": "20201201", "listing_expiration_date": "20261231"}