dexmethylphenidate hydrochloride

Generic: dexmethylphenidate hydrochloride

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexmethylphenidate hydrochloride
Generic Name dexmethylphenidate hydrochloride
Labeler ascend laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dexmethylphenidate hydrochloride 5 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-656
Product ID 67877-656_d87ba2c9-5dd1-4038-8149-7ef46c421422
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212631
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2019-07-21

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 67877656
Hyphenated Format 67877-656

Supplemental Identifiers

RxCUI
899518 899548 899557
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 ANDA212631 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (67877-656-01)
  • 500 TABLET in 1 BOTTLE (67877-656-05)
  • 30 TABLET in 1 BOTTLE (67877-656-30)
source: ndc

Packages (3)

67877-656-01 100 TABLET in 1 BOTTLE (67877-656-01) 67877-656-05 500 TABLET in 1 BOTTLE (67877-656-05) 67877-656-30 30 TABLET in 1 BOTTLE (67877-656-30)

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": "d87ba2c9-5dd1-4038-8149-7ef46c421422", "openfda": {"unii": ["1678OK0E08"], "rxcui": ["899518", "899548", "899557"], "spl_set_id": ["830df993-db01-40df-beef-90af6b86f561"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (67877-656-01)", "package_ndc": "67877-656-01", "marketing_start_date": "20190721"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (67877-656-05)", "package_ndc": "67877-656-05", "marketing_start_date": "20190721"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (67877-656-30)", "package_ndc": "67877-656-30", "marketing_start_date": "20190721"}], "brand_name": "Dexmethylphenidate Hydrochloride", "product_id": "67877-656_d87ba2c9-5dd1-4038-8149-7ef46c421422", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "67877-656", "dea_schedule": "CII", "generic_name": "Dexmethylphenidate Hydrochloride", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmethylphenidate Hydrochloride", "active_ingredients": [{"name": "DEXMETHYLPHENIDATE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA212631", "marketing_category": "ANDA", "marketing_start_date": "20190721", "listing_expiration_date": "20261231"}