dextroamphetamine sulfate extended-release (0406-8961)

Drug Facts

Product Profile

Brand Name dextroamphetamine sulfate extended-release

Generic Name dextroamphetamine sulfate

Labeler specgx llc

Dosage Form CAPSULE, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

dextroamphetamine sulfate 10 mg/1

Manufacturer

SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-8961

Product ID 0406-8961_78bafc02-003f-497f-b8c0-2bb063b3fa35

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA076353

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2003-05-06

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 04068961

Hyphenated Format 0406-8961

Supplemental Identifiers

RxCUI

884520 884532 884535

UPC

0304068962011 0304068961014 0304068960017

UNII

JJ768O327N

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 dextroamphetamine sulfate extended-release (source: ndc)

Generic Name dextroamphetamine sulfate (source: ndc)

Application Number ANDA076353 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1

source: ndc

Packaging

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8961-01)

source: ndc

Packages (1)

0406-8961-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8961-01)

Ingredients (1)

dextroamphetamine sulfate (10 mg/1)

Linked Drug Pages (1)

Dextroamphetamine Sulfate Extended-Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "78bafc02-003f-497f-b8c0-2bb063b3fa35", "openfda": {"upc": ["0304068962011", "0304068961014", "0304068960017"], "unii": ["JJ768O327N"], "rxcui": ["884520", "884532", "884535"], "spl_set_id": ["69c40af8-3710-46bf-bd3d-137fe5eea23e"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8961-01)", "package_ndc": "0406-8961-01", "marketing_start_date": "20030506"}], "brand_name": "Dextroamphetamine Sulfate Extended-Release", "product_id": "0406-8961_78bafc02-003f-497f-b8c0-2bb063b3fa35", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0406-8961", "dea_schedule": "CII", "generic_name": "dextroamphetamine sulfate", "labeler_name": "SpecGx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dextroamphetamine Sulfate", "brand_name_suffix": "Extended-Release", "active_ingredients": [{"name": "DEXTROAMPHETAMINE SULFATE", "strength": "10 mg/1"}], "application_number": "ANDA076353", "marketing_category": "ANDA", "marketing_start_date": "20030506", "listing_expiration_date": "20261231"}