amphetamine sulfate

Generic: amphetamine sulfate

Labeler: granules pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amphetamine sulfate
Generic Name amphetamine sulfate
Labeler granules pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amphetamine sulfate 10 mg/1

Manufacturer
Granules Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 70010-041
Product ID 70010-041_4007e92c-5f78-73ea-e063-6394a90a92a3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212619
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2019-08-15

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 70010041
Hyphenated Format 70010-041

Supplemental Identifiers

RxCUI
884655 1600695
UPC
0370010040014 0370010041011
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 ANDA212619 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (70010-041-01)
source: ndc

Packages (1)

70010-041-01 100 TABLET in 1 BOTTLE (70010-041-01)

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": "4007e92c-5f78-73ea-e063-6394a90a92a3", "openfda": {"upc": ["0370010040014", "0370010041011"], "unii": ["6DPV8NK46S"], "rxcui": ["884655", "1600695"], "spl_set_id": ["26dbad66-13c4-4906-88b3-ab7ee191466c"], "manufacturer_name": ["Granules Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (70010-041-01)", "package_ndc": "70010-041-01", "marketing_start_date": "20190815"}], "brand_name": "Amphetamine Sulfate", "product_id": "70010-041_4007e92c-5f78-73ea-e063-6394a90a92a3", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "70010-041", "dea_schedule": "CII", "generic_name": "Amphetamine Sulfate", "labeler_name": "Granules Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amphetamine Sulfate", "active_ingredients": [{"name": "AMPHETAMINE SULFATE", "strength": "10 mg/1"}], "application_number": "ANDA212619", "marketing_category": "ANDA", "marketing_start_date": "20190815", "listing_expiration_date": "20261231"}