dexmethylphenidate hydrochloride extended-release

Generic: dexmethylphenidate hydrochloride

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

Drug Facts

Product Profile

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

dexmethylphenidate hydrochloride 30 mg/1

Manufacturer
Par Health USA, LLC

Identifiers & Regulatory

Product NDC 49884-430
Product ID 49884-430_47a67542-0c06-4542-e063-6394a90a8bfe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078992
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2013-11-19

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 49884430
Hyphenated Format 49884-430

Supplemental Identifiers

RxCUI
899461 899495
UPC
0349884123451
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 extended-release (source: ndc)
Generic Name dexmethylphenidate hydrochloride (source: ndc)
Application Number ANDA078992 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-430-01)
  • 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-430-10)
source: ndc

Packages (2)

49884-430-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-430-01) 49884-430-10 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-430-10)

Ingredients (1)

dexmethylphenidate hydrochloride (30 mg/1)

Linked Drug Pages (1)

Dexmethylphenidate Hydrochloride Extended-Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47a67542-0c06-4542-e063-6394a90a8bfe", "openfda": {"upc": ["0349884123451"], "unii": ["1678OK0E08"], "rxcui": ["899461", "899495"], "spl_set_id": ["4ed9f3c8-c71f-499e-bb91-c19847bf4444"], "manufacturer_name": ["Par Health USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-430-01)", "package_ndc": "49884-430-01", "marketing_start_date": "20131119"}, {"sample": false, "description": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-430-10)", "package_ndc": "49884-430-10", "marketing_start_date": "20131119"}], "brand_name": "Dexmethylphenidate Hydrochloride Extended-Release", "product_id": "49884-430_47a67542-0c06-4542-e063-6394a90a8bfe", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "49884-430", "dea_schedule": "CII", "generic_name": "Dexmethylphenidate Hydrochloride", "labeler_name": "Par Health USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmethylphenidate Hydrochloride", "brand_name_suffix": "Extended-Release", "active_ingredients": [{"name": "DEXMETHYLPHENIDATE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA078992", "marketing_category": "ANDA", "marketing_start_date": "20131119", "listing_expiration_date": "20271231"}