amphetamine extended-release (62542-005)

Drug Facts

Product Profile

Brand Name amphetamine extended-release

Generic Name amphetamine extended-release

Labeler neos therapeutics, lp

Dosage Form TABLET, ORALLY DISINTEGRATING

Routes

ORAL

Active Ingredients

amphetamine 3.1 mg/1

Manufacturer

Neos Therapeutics, LP

Identifiers & Regulatory

Product NDC 62542-005

Product ID 62542-005_3f9283a3-e922-36ca-e063-6394a90a409d

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category NDA AUTHORIZED GENERIC

Application Number NDA204326

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2025-09-01

Pharmacologic Class

Established (EPC)

central nervous system stimulant [epc]

Physiologic Effect

central nervous system stimulation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62542005

Hyphenated Format 62542-005

Supplemental Identifiers

RxCUI

1739803 1739813 1739819 1739825 1739831 1739837

UPC

0362542030304 0362542005302 0362542010306 0362542015301 0362542025300 0362542020305

UNII

CK833KGX7E

NUI

N0000175739 N0000175729

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 amphetamine extended-release (source: ndc)

Generic Name amphetamine extended-release (source: ndc)

Application Number NDA204326 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

3.1 mg/1

source: ndc

Packaging

30 BLISTER PACK in 1 CARTON (62542-005-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

source: ndc

Packages (1)

62542-005-30 30 BLISTER PACK in 1 CARTON (62542-005-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Ingredients (1)

amphetamine (3.1 mg/1)

Linked Drug Pages (1)

Amphetamine Extended-Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "3f9283a3-e922-36ca-e063-6394a90a409d", "openfda": {"nui": ["N0000175739", "N0000175729"], "upc": ["0362542030304", "0362542005302", "0362542010306", "0362542015301", "0362542025300", "0362542020305"], "unii": ["CK833KGX7E"], "rxcui": ["1739803", "1739813", "1739819", "1739825", "1739831", "1739837"], "spl_set_id": ["48d0f55c-f847-4d26-b2ed-94b5a2770228"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]"], "pharm_class_epc": ["Central Nervous System Stimulant [EPC]"], "manufacturer_name": ["Neos Therapeutics, LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (62542-005-30)  / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "62542-005-30", "marketing_start_date": "20250901"}], "brand_name": "Amphetamine Extended-Release", "product_id": "62542-005_3f9283a3-e922-36ca-e063-6394a90a409d", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "62542-005", "dea_schedule": "CII", "generic_name": "Amphetamine Extended-Release", "labeler_name": "Neos Therapeutics, LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amphetamine Extended-Release", "active_ingredients": [{"name": "AMPHETAMINE", "strength": "3.1 mg/1"}], "application_number": "NDA204326", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20250901", "listing_expiration_date": "20261231"}