methylphenidate hydrochloride

Generic: methylphenidate hydrochloride

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylphenidate hydrochloride
Generic Name methylphenidate hydrochloride
Labeler ascend laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 10 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-617
Product ID 67877-617_c6ff917f-4793-4098-b8b8-e1b31f10677b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211779
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2019-10-06

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 67877617
Hyphenated Format 67877-617

Supplemental Identifiers

RxCUI
1091150 1091392 1091497
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 ANDA211779 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (67877-617-01)
  • 10 BLISTER PACK in 1 CARTON (67877-617-33) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

67877-617-01 100 TABLET in 1 BOTTLE (67877-617-01) 67877-617-33 10 BLISTER PACK in 1 CARTON (67877-617-33) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

methylphenidate hydrochloride (10 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": "c6ff917f-4793-4098-b8b8-e1b31f10677b", "openfda": {"unii": ["4B3SC438HI"], "rxcui": ["1091150", "1091392", "1091497"], "spl_set_id": ["8e97c9f3-956c-416a-a7c2-68bb92053ce5"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (67877-617-01)", "package_ndc": "67877-617-01", "marketing_start_date": "20191006"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (67877-617-33)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "67877-617-33", "marketing_start_date": "20191006"}], "brand_name": "Methylphenidate Hydrochloride", "product_id": "67877-617_c6ff917f-4793-4098-b8b8-e1b31f10677b", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "67877-617", "dea_schedule": "CII", "generic_name": "Methylphenidate Hydrochloride", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylphenidate Hydrochloride", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA211779", "marketing_category": "ANDA", "marketing_start_date": "20191006", "listing_expiration_date": "20261231"}