methylphenidate hydrochloride

Generic: methylphenidate hydrochloride

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

Drug Facts

Product Profile

Brand Name methylphenidate hydrochloride
Generic Name methylphenidate hydrochloride
Labeler ascent pharmaceuticals, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

methylphenidate 10 mg/5mL

Manufacturer
Ascent Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43602-178
Product ID 43602-178_eadd6980-7aad-464b-9ce8-cf7b1a20064d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207417
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2021-01-29

Pharmacologic Class

Established (EPC)
central nervous system stimulant [epc]
Physiologic Effect
central nervous system stimulation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43602178
Hyphenated Format 43602-178

Supplemental Identifiers

RxCUI
1091133 1091341
UPC
0343602178259 0343602177252
UNII
207ZZ9QZ49
NUI
N0000175739 N0000175729

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 ANDA207417 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
source: ndc
Packaging
  • 500 mL in 1 BOTTLE (43602-178-05)
  • 250 mL in 1 BOTTLE (43602-178-25)
source: ndc

Packages (2)

43602-178-05 500 mL in 1 BOTTLE (43602-178-05) 43602-178-25 250 mL in 1 BOTTLE (43602-178-25)

Ingredients (1)

methylphenidate (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": "eadd6980-7aad-464b-9ce8-cf7b1a20064d", "openfda": {"nui": ["N0000175739", "N0000175729"], "upc": ["0343602178259", "0343602177252"], "unii": ["207ZZ9QZ49"], "rxcui": ["1091133", "1091341"], "spl_set_id": ["45ebb59c-9603-4df6-b1be-3295ba2db1e7"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]"], "pharm_class_epc": ["Central Nervous System Stimulant [EPC]"], "manufacturer_name": ["Ascent Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 mL in 1 BOTTLE (43602-178-05)", "package_ndc": "43602-178-05", "marketing_start_date": "20210129"}, {"sample": false, "description": "250 mL in 1 BOTTLE (43602-178-25)", "package_ndc": "43602-178-25", "marketing_start_date": "20210129"}], "brand_name": "Methylphenidate Hydrochloride", "product_id": "43602-178_eadd6980-7aad-464b-9ce8-cf7b1a20064d", "dosage_form": "SOLUTION", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "43602-178", "dea_schedule": "CII", "generic_name": "Methylphenidate Hydrochloride", "labeler_name": "Ascent Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylphenidate Hydrochloride", "active_ingredients": [{"name": "METHYLPHENIDATE", "strength": "10 mg/5mL"}], "application_number": "ANDA207417", "marketing_category": "ANDA", "marketing_start_date": "20210129", "listing_expiration_date": "20261231"}