metadate cd

Generic: methylphenidate hydrochloride

Labeler: aytu biopharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name metadate cd
Generic Name methylphenidate hydrochloride
Labeler aytu biopharma, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 40 mg/1

Manufacturer
Aytu BioPharma, Inc.

Identifiers & Regulatory

Product NDC 69654-582
Product ID 69654-582_43e0b75f-01c3-28cd-e063-6394a90a74a8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021259
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2024-02-22

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 69654582
Hyphenated Format 69654-582

Supplemental Identifiers

RxCUI
1091139 1091163 1091178 1091193 1091204 1091220 1806181 1806187 1806189 1806191 1806193 1806197
UPC
0369654583308 0369654579301 0369654581304 0369654584305 0369654582301 0369654580307
UNII
4B3SC438HI

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 metadate cd (source: ndc)
Generic Name methylphenidate hydrochloride (source: ndc)
Application Number NDA021259 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69654-582-30)
source: ndc

Packages (1)

69654-582-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69654-582-30)

Ingredients (1)

methylphenidate hydrochloride (40 mg/1)

Linked Drug Pages (1)

METADATE CD ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "43e0b75f-01c3-28cd-e063-6394a90a74a8", "openfda": {"upc": ["0369654583308", "0369654579301", "0369654581304", "0369654584305", "0369654582301", "0369654580307"], "unii": ["4B3SC438HI"], "rxcui": ["1091139", "1091163", "1091178", "1091193", "1091204", "1091220", "1806181", "1806187", "1806189", "1806191", "1806193", "1806197"], "spl_set_id": ["be59f8b4-7842-42cc-9559-bfa747f0baa5"], "manufacturer_name": ["Aytu BioPharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69654-582-30)", "package_ndc": "69654-582-30", "marketing_start_date": "20240222"}], "brand_name": "METADATE CD", "product_id": "69654-582_43e0b75f-01c3-28cd-e063-6394a90a74a8", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "69654-582", "dea_schedule": "CII", "generic_name": "methylphenidate hydrochloride", "labeler_name": "Aytu BioPharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METADATE CD", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "NDA021259", "marketing_category": "NDA", "marketing_start_date": "20240222", "listing_expiration_date": "20261231"}