methylphenidate hydrochloride

Generic: methylphenidate hydrochloride

Labeler: aurolife pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylphenidate hydrochloride
Generic Name methylphenidate hydrochloride
Labeler aurolife pharma, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 20 mg/1

Manufacturer
Aurolife Pharma, LLC

Identifiers & Regulatory

Product NDC 13107-382
Product ID 13107-382_f821bfff-5013-4850-8e10-33e5c146df4a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209276
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2017-04-11

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 13107382
Hyphenated Format 13107-382

Supplemental Identifiers

RxCUI
1091150 1091392 1091497
UPC
0313107381010 0313107382017 0313107380013
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 ANDA209276 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (13107-382-01)
source: ndc

Packages (1)

13107-382-01 100 TABLET in 1 BOTTLE (13107-382-01)

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": "f821bfff-5013-4850-8e10-33e5c146df4a", "openfda": {"upc": ["0313107381010", "0313107382017", "0313107380013"], "unii": ["4B3SC438HI"], "rxcui": ["1091150", "1091392", "1091497"], "spl_set_id": ["35be77db-fbe3-487e-a220-a08a11aaec28"], "manufacturer_name": ["Aurolife Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (13107-382-01)", "package_ndc": "13107-382-01", "marketing_start_date": "20170411"}], "brand_name": "Methylphenidate Hydrochloride", "product_id": "13107-382_f821bfff-5013-4850-8e10-33e5c146df4a", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "13107-382", "dea_schedule": "CII", "generic_name": "Methylphenidate Hydrochloride", "labeler_name": "Aurolife Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylphenidate Hydrochloride", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA209276", "marketing_category": "ANDA", "marketing_start_date": "20170411", "listing_expiration_date": "20261231"}