methylphenidate hydrochloride

Generic: methylphenidate hydrochloride

Labeler: quagen pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylphenidate hydrochloride
Generic Name methylphenidate hydrochloride
Labeler quagen pharmaceuticals llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 5 mg/5mL

Manufacturer
QUAGEN PHARMACEUTICALS LLC

Identifiers & Regulatory

Product NDC 70752-131
Product ID 70752-131_80b36f9d-4d27-46af-837b-70d2daec0dba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213567
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2020-06-04

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 70752131
Hyphenated Format 70752-131

Supplemental Identifiers

RxCUI
1091133 1091341
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 ANDA213567 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 500 mL in 1 BOTTLE, PLASTIC (70752-131-14)
source: ndc

Packages (1)

70752-131-14 500 mL in 1 BOTTLE, PLASTIC (70752-131-14)

Ingredients (1)

methylphenidate hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

METHYLPHENIDATE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "80b36f9d-4d27-46af-837b-70d2daec0dba", "openfda": {"unii": ["4B3SC438HI"], "rxcui": ["1091133", "1091341"], "spl_set_id": ["59de488c-c3f8-415d-9e9f-9102c090aac8"], "manufacturer_name": ["QUAGEN PHARMACEUTICALS LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 mL in 1 BOTTLE, PLASTIC (70752-131-14)", "package_ndc": "70752-131-14", "marketing_start_date": "20200604"}], "brand_name": "METHYLPHENIDATE HYDROCHLORIDE", "product_id": "70752-131_80b36f9d-4d27-46af-837b-70d2daec0dba", "dosage_form": "SOLUTION", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "70752-131", "dea_schedule": "CII", "generic_name": "METHYLPHENIDATE HYDROCHLORIDE", "labeler_name": "QUAGEN PHARMACEUTICALS LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METHYLPHENIDATE HYDROCHLORIDE", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "ANDA213567", "marketing_category": "ANDA", "marketing_start_date": "20200604", "listing_expiration_date": "20261231"}