dexmethylphenidate hydrochloride

Generic: dexmethylphenidate hydrochloride

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

Drug Facts

Product Profile

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

dexmethylphenidate hydrochloride 10 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-230
Product ID 31722-230_81c8ba81-82ac-4c18-b28b-da9c71520f35
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215523
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2021-12-08

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 31722230
Hyphenated Format 31722-230

Supplemental Identifiers

RxCUI
899439 899461 899485 899495 899511 1006608 1101926 1101932
UPC
0331722233019 0331722229012 0331722234016 0331722235013 0331722231015 0331722236010 0331722232012 0331722230018
UNII
1678OK0E08

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 dexmethylphenidate hydrochloride (source: ndc)
Generic Name dexmethylphenidate hydrochloride (source: ndc)
Application Number ANDA215523 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-230-01)
source: ndc

Packages (1)

31722-230-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-230-01)

Ingredients (1)

dexmethylphenidate hydrochloride (10 mg/1)

Linked Drug Pages (1)

DEXMETHYLPHENIDATE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "81c8ba81-82ac-4c18-b28b-da9c71520f35", "openfda": {"upc": ["0331722233019", "0331722229012", "0331722234016", "0331722235013", "0331722231015", "0331722236010", "0331722232012", "0331722230018"], "unii": ["1678OK0E08"], "rxcui": ["899439", "899461", "899485", "899495", "899511", "1006608", "1101926", "1101932"], "spl_set_id": ["77659abe-74be-4092-90fe-cc475726d4ec"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-230-01)", "package_ndc": "31722-230-01", "marketing_start_date": "20211208"}], "brand_name": "DEXMETHYLPHENIDATE HYDROCHLORIDE", "product_id": "31722-230_81c8ba81-82ac-4c18-b28b-da9c71520f35", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "31722-230", "dea_schedule": "CII", "generic_name": "dexmethylphenidate hydrochloride", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DEXMETHYLPHENIDATE HYDROCHLORIDE", "active_ingredients": [{"name": "DEXMETHYLPHENIDATE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA215523", "marketing_category": "ANDA", "marketing_start_date": "20211208", "listing_expiration_date": "20261231"}