amphetamine sulfate

Generic: amphetamine sulfate

Labeler: specgx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amphetamine sulfate
Generic Name amphetamine sulfate
Labeler specgx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amphetamine sulfate 5 mg/1

Manufacturer
SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-1219
Product ID 0406-1219_8fdfec51-e7c0-429b-a3f4-8f5ae2679147
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213583
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2021-02-28

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 04061219
Hyphenated Format 0406-1219

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 ANDA213583 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0406-1219-01)
source: ndc

Packages (1)

0406-1219-01 100 TABLET in 1 BOTTLE (0406-1219-01)

Ingredients (1)

amphetamine sulfate (5 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": "8fdfec51-e7c0-429b-a3f4-8f5ae2679147", "openfda": {"unii": ["6DPV8NK46S"], "rxcui": ["884655", "1600695"], "spl_set_id": ["00242264-40d8-4267-a91a-727a1f088616"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0406-1219-01)", "package_ndc": "0406-1219-01", "marketing_start_date": "20210228"}], "brand_name": "Amphetamine Sulfate", "product_id": "0406-1219_8fdfec51-e7c0-429b-a3f4-8f5ae2679147", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0406-1219", "dea_schedule": "CII", "generic_name": "Amphetamine Sulfate", "labeler_name": "SpecGx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amphetamine Sulfate", "active_ingredients": [{"name": "AMPHETAMINE SULFATE", "strength": "5 mg/1"}], "application_number": "ANDA213583", "marketing_category": "ANDA", "marketing_start_date": "20210228", "listing_expiration_date": "20261231"}