dexmethylphenidate hydrochloride extended-release

Generic: dexmethylphenidate hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexmethylphenidate hydrochloride extended-release
Generic Name dexmethylphenidate hydrochloride
Labeler bryant ranch prepack
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

dexmethylphenidate hydrochloride 15 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-2172
Product ID 63629-2172_0556dbb2-50c2-4dd6-8f20-5819b4fc8051
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078992
DEA Schedule cii
Listing Expiration 2026-12-31
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 636292172
Hyphenated Format 63629-2172

Supplemental Identifiers

RxCUI
899461
UNII
1678OK0E08

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
  • 15 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-2172-1)
source: ndc

Packages (1)

63629-2172-1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-2172-1)

Ingredients (1)

dexmethylphenidate hydrochloride (15 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": "0556dbb2-50c2-4dd6-8f20-5819b4fc8051", "openfda": {"unii": ["1678OK0E08"], "rxcui": ["899461"], "spl_set_id": ["bb4f32eb-05c7-449e-8e5a-f45781a58f70"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-2172-1)", "package_ndc": "63629-2172-1", "marketing_start_date": "20131119"}], "brand_name": "Dexmethylphenidate Hydrochloride Extended-Release", "product_id": "63629-2172_0556dbb2-50c2-4dd6-8f20-5819b4fc8051", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "63629-2172", "dea_schedule": "CII", "generic_name": "Dexmethylphenidate Hydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmethylphenidate Hydrochloride", "brand_name_suffix": "Extended-Release", "active_ingredients": [{"name": "DEXMETHYLPHENIDATE HYDROCHLORIDE", "strength": "15 mg/1"}], "application_number": "ANDA078992", "marketing_category": "ANDA", "marketing_start_date": "20131119", "listing_expiration_date": "20261231"}