dextroamphetamine sulfate extended-release

Generic: dextroamphetamine sulfate

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name dextroamphetamine sulfate extended-release
Generic Name dextroamphetamine sulfate
Labeler amneal pharmaceuticals of new york llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

dextroamphetamine sulfate 10 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-9928
Product ID 0115-9928_42b19d09-cffd-4772-bc84-76c2066d6f00
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA017078
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 1976-08-02

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 01159928
Hyphenated Format 0115-9928

Supplemental Identifiers

RxCUI
884520 884532 884535
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 NDA017078 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-9928-10)
source: ndc

Packages (1)

0115-9928-10 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-9928-10)

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": "42b19d09-cffd-4772-bc84-76c2066d6f00", "openfda": {"unii": ["JJ768O327N"], "rxcui": ["884520", "884532", "884535"], "spl_set_id": ["2ec5c30f-4eb8-48a5-83c4-236450413464"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-9928-10)", "package_ndc": "0115-9928-10", "marketing_start_date": "19760802"}], "brand_name": "Dextroamphetamine Sulfate Extended-Release", "product_id": "0115-9928_42b19d09-cffd-4772-bc84-76c2066d6f00", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0115-9928", "dea_schedule": "CII", "generic_name": "Dextroamphetamine Sulfate", "labeler_name": "Amneal Pharmaceuticals of New York 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": "NDA017078", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "19760802", "listing_expiration_date": "20261231"}