dextroamphetamine sulfate

Generic: dextroamphetamine sulfate

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dextroamphetamine sulfate
Generic Name dextroamphetamine sulfate
Labeler teva pharmaceuticals usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dextroamphetamine sulfate 10 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0555-0953
Product ID 0555-0953_05934bca-3ed9-4ce3-ba1d-2063930aad63
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040361
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2001-02-12

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 05550953
Hyphenated Format 0555-0953

Supplemental Identifiers

RxCUI
884385 884386
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 ANDA040361 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0555-0953-02)
source: ndc

Packages (1)

0555-0953-02 100 TABLET in 1 BOTTLE (0555-0953-02)

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": "05934bca-3ed9-4ce3-ba1d-2063930aad63", "openfda": {"unii": ["JJ768O327N"], "rxcui": ["884385", "884386"], "spl_set_id": ["ec2d13f3-d14f-47e4-abe9-7763f95a8e94"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0555-0953-02)", "package_ndc": "0555-0953-02", "marketing_start_date": "20010212"}], "brand_name": "Dextroamphetamine Sulfate", "product_id": "0555-0953_05934bca-3ed9-4ce3-ba1d-2063930aad63", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0555-0953", "dea_schedule": "CII", "generic_name": "Dextroamphetamine Sulfate", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dextroamphetamine Sulfate", "active_ingredients": [{"name": "DEXTROAMPHETAMINE SULFATE", "strength": "10 mg/1"}], "application_number": "ANDA040361", "marketing_category": "ANDA", "marketing_start_date": "20010212", "listing_expiration_date": "20271231"}