methylphenidate hcl

Generic: methylphenidate hcl

Labeler: patrin pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylphenidate hcl
Generic Name methylphenidate hcl
Labeler patrin pharma, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 5 mg/5mL

Manufacturer
Patrin Pharma, Inc.

Identifiers & Regulatory

Product NDC 39328-054
Product ID 39328-054_604deb17-dd9e-4386-a52b-248b1d5cb6b7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210764
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2020-04-23

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 39328054
Hyphenated Format 39328-054

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 hcl (source: ndc)
Generic Name methylphenidate hcl (source: ndc)
Application Number ANDA210764 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 500 mL in 1 BOTTLE (39328-054-50)
source: ndc

Packages (1)

39328-054-50 500 mL in 1 BOTTLE (39328-054-50)

Ingredients (1)

methylphenidate hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

Methylphenidate HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "604deb17-dd9e-4386-a52b-248b1d5cb6b7", "openfda": {"unii": ["4B3SC438HI"], "rxcui": ["1091133", "1091341"], "spl_set_id": ["7d66dbf9-3966-4949-b7c9-d2ca8c7f3278"], "manufacturer_name": ["Patrin Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 mL in 1 BOTTLE (39328-054-50)", "package_ndc": "39328-054-50", "marketing_start_date": "20200423"}], "brand_name": "Methylphenidate HCl", "product_id": "39328-054_604deb17-dd9e-4386-a52b-248b1d5cb6b7", "dosage_form": "SOLUTION", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "39328-054", "dea_schedule": "CII", "generic_name": "Methylphenidate HCl", "labeler_name": "Patrin Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylphenidate HCl", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "ANDA210764", "marketing_category": "ANDA", "marketing_start_date": "20200423", "listing_expiration_date": "20261231"}