amphetamine sulfate

Generic: amphetamine sulfate

Labeler: solco healthcare us, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amphetamine sulfate
Generic Name amphetamine sulfate
Labeler solco healthcare us, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amphetamine sulfate 10 mg/1

Manufacturer
Solco Healthcare US, LLC

Identifiers & Regulatory

Product NDC 43547-458
Product ID 43547-458_b11d796e-584c-49a4-9f05-b499f5cd0f5e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211861
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2020-04-02

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 43547458
Hyphenated Format 43547-458

Supplemental Identifiers

RxCUI
884655 1600695
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 ANDA211861 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (43547-458-10)
source: ndc

Packages (1)

43547-458-10 100 TABLET in 1 BOTTLE (43547-458-10)

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": "b11d796e-584c-49a4-9f05-b499f5cd0f5e", "openfda": {"unii": ["6DPV8NK46S"], "rxcui": ["884655", "1600695"], "spl_set_id": ["89c5b52f-3c2a-41d5-8624-9ee51c512c72"], "manufacturer_name": ["Solco Healthcare US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (43547-458-10)", "package_ndc": "43547-458-10", "marketing_start_date": "20200402"}], "brand_name": "AMPHETAMINE SULFATE", "product_id": "43547-458_b11d796e-584c-49a4-9f05-b499f5cd0f5e", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "43547-458", "dea_schedule": "CII", "generic_name": "amphetamine sulfate", "labeler_name": "Solco Healthcare US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMPHETAMINE SULFATE", "active_ingredients": [{"name": "AMPHETAMINE SULFATE", "strength": "10 mg/1"}], "application_number": "ANDA211861", "marketing_category": "ANDA", "marketing_start_date": "20200402", "listing_expiration_date": "20261231"}