methylphenidate hydrochloride

Generic: methylphenidate hydrochloride

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

Drug Facts

Product Profile

Brand Name methylphenidate hydrochloride
Generic Name methylphenidate hydrochloride
Labeler lupin pharmaceuticals,inc.
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 5 mg/1

Manufacturer
Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-571
Product ID 43386-571_c9e22f02-1ba0-41b6-ad52-181d18094553
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204115
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2015-04-06

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 43386571
Hyphenated Format 43386-571

Supplemental Identifiers

RxCUI
1091152 1091322 1091389
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 ANDA204115 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, CHEWABLE in 1 BOTTLE (43386-571-01)
source: ndc

Packages (1)

43386-571-01 100 TABLET, CHEWABLE in 1 BOTTLE (43386-571-01)

Ingredients (1)

methylphenidate hydrochloride (5 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": "c9e22f02-1ba0-41b6-ad52-181d18094553", "openfda": {"unii": ["4B3SC438HI"], "rxcui": ["1091152", "1091322", "1091389"], "spl_set_id": ["5bfe50ed-171f-4c40-bc0b-20c68e8e2025"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, CHEWABLE in 1 BOTTLE (43386-571-01)", "package_ndc": "43386-571-01", "marketing_start_date": "20150406"}], "brand_name": "Methylphenidate Hydrochloride", "product_id": "43386-571_c9e22f02-1ba0-41b6-ad52-181d18094553", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "43386-571", "dea_schedule": "CII", "generic_name": "Methylphenidate Hydrochloride", "labeler_name": "Lupin Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylphenidate Hydrochloride", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA204115", "marketing_category": "ANDA", "marketing_start_date": "20150406", "listing_expiration_date": "20261231"}