dextroamphetamine sulfate

Generic: dextroamphetamine sulfate

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dextroamphetamine sulfate
Generic Name dextroamphetamine sulfate
Labeler actavis pharma, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

dextroamphetamine sulfate 10 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 45963-304
Product ID 45963-304_352be1be-4f30-4afe-9ec2-6108c1b9a9d7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203901
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2014-06-19

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 45963304
Hyphenated Format 45963-304

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 (source: ndc)
Generic Name dextroamphetamine sulfate (source: ndc)
Application Number ANDA203901 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-304-09)
source: ndc

Packages (1)

45963-304-09 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-304-09)

Ingredients (1)

dextroamphetamine sulfate (10 mg/1)

Linked Drug Pages (1)

dextroamphetamine sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "352be1be-4f30-4afe-9ec2-6108c1b9a9d7", "openfda": {"unii": ["JJ768O327N"], "rxcui": ["884520", "884532", "884535"], "spl_set_id": ["9e92ccc3-d81c-461d-a19f-7e9b582be357"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-304-09)", "package_ndc": "45963-304-09", "marketing_start_date": "20140619"}], "brand_name": "dextroamphetamine sulfate", "product_id": "45963-304_352be1be-4f30-4afe-9ec2-6108c1b9a9d7", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "45963-304", "dea_schedule": "CII", "generic_name": "dextroamphetamine sulfate", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "dextroamphetamine sulfate", "active_ingredients": [{"name": "DEXTROAMPHETAMINE SULFATE", "strength": "10 mg/1"}], "application_number": "ANDA203901", "marketing_category": "ANDA", "marketing_start_date": "20140619", "listing_expiration_date": "20261231"}