dexmethylphenidate hydrochloride

Generic: dexmethylphenidate hydrochloride

Labeler: par health usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexmethylphenidate hydrochloride
Generic Name dexmethylphenidate hydrochloride
Labeler par health usa, llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

dexmethylphenidate hydrochloride 5 mg/1

Manufacturer
Par Health USA, LLC

Identifiers & Regulatory

Product NDC 49884-048
Product ID 49884-048_09fcee97-8b48-4a1d-a380-0e01c92e0e9b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202842
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2017-01-05

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 49884048
Hyphenated Format 49884-048

Supplemental Identifiers

RxCUI
899439 899461 899485 899495 899511 1006608 1101926 1101932
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 ANDA202842 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-048-01)
source: ndc

Packages (1)

49884-048-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-048-01)

Ingredients (1)

dexmethylphenidate hydrochloride (5 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": "09fcee97-8b48-4a1d-a380-0e01c92e0e9b", "openfda": {"unii": ["1678OK0E08"], "rxcui": ["899439", "899461", "899485", "899495", "899511", "1006608", "1101926", "1101932"], "spl_set_id": ["e304388e-86a6-4335-abae-0ce79c7c99c6"], "manufacturer_name": ["Par Health USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-048-01)", "package_ndc": "49884-048-01", "marketing_start_date": "20170105"}], "brand_name": "Dexmethylphenidate Hydrochloride", "product_id": "49884-048_09fcee97-8b48-4a1d-a380-0e01c92e0e9b", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "49884-048", "dea_schedule": "CII", "generic_name": "Dexmethylphenidate Hydrochloride", "labeler_name": "Par Health USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmethylphenidate Hydrochloride", "active_ingredients": [{"name": "DEXMETHYLPHENIDATE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA202842", "marketing_category": "ANDA", "marketing_start_date": "20170105", "listing_expiration_date": "20261231"}