dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate

Generic: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate

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

Drug Facts

Product Profile

Brand Name dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate
Generic Name dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate
Labeler camber pharmaceuticals, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

amphetamine aspartate monohydrate 7.5 mg/1, amphetamine sulfate 7.5 mg/1, dextroamphetamine saccharate 7.5 mg/1, dextroamphetamine sulfate 7.5 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-195
Product ID 31722-195_02105fa1-4728-4954-b2af-8444bf122364
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214959
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2021-09-29

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 31722195
Hyphenated Format 31722-195

Supplemental Identifiers

RxCUI
861221 861223 861225 861227 861232 861237
UPC
0331722188012 0331722186018 0331722189019 0331722187015 0331722195010 0331722185011
UNII
O1ZPV620O4 6DPV8NK46S G83415V073 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 saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (source: ndc)
Generic Name dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (source: ndc)
Application Number ANDA214959 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-195-01)
source: ndc

Packages (1)

31722-195-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-195-01)

Ingredients (4)

amphetamine aspartate monohydrate (7.5 mg/1) amphetamine sulfate (7.5 mg/1) dextroamphetamine saccharate (7.5 mg/1) dextroamphetamine sulfate (7.5 mg/1)

Linked Drug Pages (1)

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "02105fa1-4728-4954-b2af-8444bf122364", "openfda": {"upc": ["0331722188012", "0331722186018", "0331722189019", "0331722187015", "0331722195010", "0331722185011"], "unii": ["O1ZPV620O4", "6DPV8NK46S", "G83415V073", "JJ768O327N"], "rxcui": ["861221", "861223", "861225", "861227", "861232", "861237"], "spl_set_id": ["1fc35735-569c-4dcd-b6c6-14443a043de5"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-195-01)", "package_ndc": "31722-195-01", "marketing_start_date": "20210929"}], "brand_name": "DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE", "product_id": "31722-195_02105fa1-4728-4954-b2af-8444bf122364", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]", "Central Nervous System Stimulation [PE]", "Central Nervous System Stimulation [PE]", "Central Nervous System Stimulation [PE]"], "product_ndc": "31722-195", "dea_schedule": "CII", "generic_name": "dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE", "active_ingredients": [{"name": "AMPHETAMINE ASPARTATE MONOHYDRATE", "strength": "7.5 mg/1"}, {"name": "AMPHETAMINE SULFATE", "strength": "7.5 mg/1"}, {"name": "DEXTROAMPHETAMINE SACCHARATE", "strength": "7.5 mg/1"}, {"name": "DEXTROAMPHETAMINE SULFATE", "strength": "7.5 mg/1"}], "application_number": "ANDA214959", "marketing_category": "ANDA", "marketing_start_date": "20210929", "listing_expiration_date": "20261231"}