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 SOLUTION
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 10 mg/5mL

Manufacturer
Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-931
Product ID 43386-931_69b5f215-076c-47d1-9250-1406016a5679
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204602
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2015-12-15

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 43386931
Hyphenated Format 43386-931

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 ANDA204602 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
source: ndc
Packaging
  • 500 mL in 1 BOTTLE (43386-931-05)
source: ndc

Packages (1)

43386-931-05 500 mL in 1 BOTTLE (43386-931-05)

Ingredients (1)

methylphenidate hydrochloride (10 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": "69b5f215-076c-47d1-9250-1406016a5679", "openfda": {"unii": ["4B3SC438HI"], "rxcui": ["1091133", "1091341"], "spl_set_id": ["57fd619e-687d-403c-a77a-3dc3a1bab65a"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 mL in 1 BOTTLE (43386-931-05)", "package_ndc": "43386-931-05", "marketing_start_date": "20151215"}], "brand_name": "Methylphenidate Hydrochloride", "product_id": "43386-931_69b5f215-076c-47d1-9250-1406016a5679", "dosage_form": "SOLUTION", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "43386-931", "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": "10 mg/5mL"}], "application_number": "ANDA204602", "marketing_category": "ANDA", "marketing_start_date": "20151215", "listing_expiration_date": "20261231"}