methylphenidate hydrochloride

Generic: methylphenidate hydrochloride

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

Drug Facts

Product Profile

Brand Name methylphenidate hydrochloride
Generic Name methylphenidate hydrochloride
Labeler camber pharmaceuticals, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 54 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-955
Product ID 31722-955_1d1d77b9-0f73-4daf-8ca6-0837caa03bac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211009
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2019-09-03

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 31722955
Hyphenated Format 31722-955

Supplemental Identifiers

RxCUI
1091155 1091170 1091185 1091210
UPC
0331722955010 0331722954013 0331722952019 0331722953016
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 ANDA211009 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 54 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-955-01)
source: ndc

Packages (1)

31722-955-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-955-01)

Ingredients (1)

methylphenidate hydrochloride (54 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": "1d1d77b9-0f73-4daf-8ca6-0837caa03bac", "openfda": {"upc": ["0331722955010", "0331722954013", "0331722952019", "0331722953016"], "unii": ["4B3SC438HI"], "rxcui": ["1091155", "1091170", "1091185", "1091210"], "spl_set_id": ["b9af3104-172d-4975-9301-b9fe7db9ef12"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-955-01)", "package_ndc": "31722-955-01", "marketing_start_date": "20190903"}], "brand_name": "Methylphenidate Hydrochloride", "product_id": "31722-955_1d1d77b9-0f73-4daf-8ca6-0837caa03bac", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "31722-955", "dea_schedule": "CII", "generic_name": "Methylphenidate Hydrochloride", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylphenidate Hydrochloride", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "54 mg/1"}], "application_number": "ANDA211009", "marketing_category": "ANDA", "marketing_start_date": "20190903", "listing_expiration_date": "20261231"}