methylphenidate hydrochloride

Generic: methylphenidate hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylphenidate hydrochloride
Generic Name methylphenidate hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 36 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 57664-608
Product ID 57664-608_4cc08110-a74b-4d85-e063-6294a90ab854
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205135
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2020-08-20

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 57664608
Hyphenated Format 57664-608

Supplemental Identifiers

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 ANDA205135 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 36 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (57664-608-88)
source: ndc

Packages (1)

57664-608-88 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (57664-608-88)

Ingredients (1)

methylphenidate hydrochloride (36 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": "4cc08110-a74b-4d85-e063-6294a90ab854", "openfda": {"unii": ["4B3SC438HI"], "spl_set_id": ["d048e52d-7406-4fc1-9a72-c073bafc7439"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (57664-608-88)", "package_ndc": "57664-608-88", "marketing_start_date": "20200820"}], "brand_name": "Methylphenidate Hydrochloride", "product_id": "57664-608_4cc08110-a74b-4d85-e063-6294a90ab854", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "57664-608", "dea_schedule": "CII", "generic_name": "Methylphenidate Hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylphenidate Hydrochloride", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "36 mg/1"}], "application_number": "ANDA205135", "marketing_category": "ANDA", "marketing_start_date": "20200820", "listing_expiration_date": "20271231"}