methylphenidate hydrochloride

Generic: methylphenidate hydrochloride

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylphenidate hydrochloride
Generic Name methylphenidate hydrochloride
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 5 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-805
Product ID 68084-805_41c22d0f-0fbe-e5af-e063-6294a90a47c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040300
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2014-09-30

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 68084805
Hyphenated Format 68084-805

Supplemental Identifiers

RxCUI
1091150 1091497
UNII
4B3SC438HI

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 ANDA040300 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-805-21) / 1 TABLET in 1 BLISTER PACK (68084-805-11)
source: ndc

Packages (1)

68084-805-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-805-21) / 1 TABLET in 1 BLISTER PACK (68084-805-11)

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": "41c22d0f-0fbe-e5af-e063-6294a90a47c0", "openfda": {"unii": ["4B3SC438HI"], "rxcui": ["1091150", "1091497"], "spl_set_id": ["eb9b7377-d918-43fb-8e82-d14c85ed64a8"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-805-21)  / 1 TABLET in 1 BLISTER PACK (68084-805-11)", "package_ndc": "68084-805-21", "marketing_start_date": "20140930"}], "brand_name": "Methylphenidate Hydrochloride", "product_id": "68084-805_41c22d0f-0fbe-e5af-e063-6294a90a47c0", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "68084-805", "dea_schedule": "CII", "generic_name": "Methylphenidate Hydrochloride", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylphenidate Hydrochloride", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA040300", "marketing_category": "ANDA", "marketing_start_date": "20140930", "listing_expiration_date": "20261231"}