amphetamine sulfate

Generic: amphetamine sulfate

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amphetamine sulfate
Generic Name amphetamine sulfate
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amphetamine sulfate 10 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 57664-075
Product ID 57664-075_358e58ef-fbfb-9fba-e063-6394a90ac57e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214574
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2021-01-27

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 57664075
Hyphenated Format 57664-075

Supplemental Identifiers

RxCUI
884655 1600695
UPC
0357664062883
UNII
6DPV8NK46S

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 amphetamine sulfate (source: ndc)
Generic Name amphetamine sulfate (source: ndc)
Application Number ANDA214574 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (57664-075-88)
source: ndc

Packages (1)

57664-075-88 100 TABLET in 1 BOTTLE (57664-075-88)

Ingredients (1)

amphetamine sulfate (10 mg/1)

Linked Drug Pages (1)

Amphetamine Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "358e58ef-fbfb-9fba-e063-6394a90ac57e", "openfda": {"upc": ["0357664062883"], "unii": ["6DPV8NK46S"], "rxcui": ["884655", "1600695"], "spl_set_id": ["8fa41f19-0b2b-4b6a-aa5f-d28f8213a6bc"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (57664-075-88)", "package_ndc": "57664-075-88", "marketing_start_date": "20210127"}], "brand_name": "Amphetamine Sulfate", "product_id": "57664-075_358e58ef-fbfb-9fba-e063-6394a90ac57e", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "57664-075", "dea_schedule": "CII", "generic_name": "Amphetamine Sulfate", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amphetamine Sulfate", "active_ingredients": [{"name": "AMPHETAMINE SULFATE", "strength": "10 mg/1"}], "application_number": "ANDA214574", "marketing_category": "ANDA", "marketing_start_date": "20210127", "listing_expiration_date": "20261231"}