adzenys xr-odt (70165-030)

Drug Facts

Product Profile

Brand Name adzenys xr-odt

Generic Name amphetamine

Labeler neos therapeutics brands, llc

Dosage Form TABLET, ORALLY DISINTEGRATING

Routes

ORAL

Active Ingredients

amphetamine 18.8 mg/1

Manufacturer

Neos Therapeutics Brands, LLC

Identifiers & Regulatory

Product NDC 70165-030

Product ID 70165-030_3f92012c-7250-9c32-e063-6394a90adb47

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category NDA

Application Number NDA204326

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2016-02-16

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 70165030

Hyphenated Format 70165-030

Supplemental Identifiers

RxCUI

1739803 1739809 1739813 1739815 1739819 1739821 1739825 1739827 1739831 1739833 1739837 1739839

UPC

0370165015301 0370165010306 0370165030304 0370165005302 0370165025300 0370165020305

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 adzenys xr-odt (source: ndc)

Generic Name amphetamine (source: ndc)

Application Number NDA204326 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

18.8 mg/1

source: ndc

Packaging

30 BLISTER PACK in 1 CARTON (70165-030-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

source: ndc

Packages (1)

70165-030-30 30 BLISTER PACK in 1 CARTON (70165-030-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Ingredients (1)

amphetamine (18.8 mg/1)

Linked Drug Pages (1)

Adzenys XR-ODT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "3f92012c-7250-9c32-e063-6394a90adb47", "openfda": {"nui": ["N0000175739", "N0000175729"], "upc": ["0370165015301", "0370165010306", "0370165030304", "0370165005302", "0370165025300", "0370165020305"], "unii": ["CK833KGX7E"], "rxcui": ["1739803", "1739809", "1739813", "1739815", "1739819", "1739821", "1739825", "1739827", "1739831", "1739833", "1739837", "1739839"], "spl_set_id": ["c1179269-00b5-48ea-972d-31e614e99b7e"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]"], "pharm_class_epc": ["Central Nervous System Stimulant [EPC]"], "manufacturer_name": ["Neos Therapeutics Brands, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (70165-030-30)  / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "70165-030-30", "marketing_start_date": "20160216"}], "brand_name": "Adzenys XR-ODT", "product_id": "70165-030_3f92012c-7250-9c32-e063-6394a90adb47", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "70165-030", "dea_schedule": "CII", "generic_name": "Amphetamine", "labeler_name": "Neos Therapeutics Brands, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Adzenys XR-ODT", "active_ingredients": [{"name": "AMPHETAMINE", "strength": "18.8 mg/1"}], "application_number": "NDA204326", "marketing_category": "NDA", "marketing_start_date": "20160216", "listing_expiration_date": "20261231"}