dextroamphetamine

Generic: dextroamphetamine

Labeler: cranbury pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dextroamphetamine
Generic Name dextroamphetamine
Labeler cranbury pharmaceuticals, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

dextroamphetamine sulfate 5 mg/5mL

Manufacturer
Cranbury Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 27808-085
Product ID 27808-085_442f3920-82b4-41ab-b485-24954a2ebddb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203644
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2013-05-31

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 27808085
Hyphenated Format 27808-085

Supplemental Identifiers

RxCUI
884522
UNII
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 (source: ndc)
Generic Name dextroamphetamine (source: ndc)
Application Number ANDA203644 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE, PLASTIC (27808-085-01)
source: ndc

Packages (1)

27808-085-01 473 mL in 1 BOTTLE, PLASTIC (27808-085-01)

Ingredients (1)

dextroamphetamine sulfate (5 mg/5mL)

Linked Drug Pages (1)

Dextroamphetamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "442f3920-82b4-41ab-b485-24954a2ebddb", "openfda": {"unii": ["JJ768O327N"], "rxcui": ["884522"], "spl_set_id": ["7658071e-ee2c-4d23-94ce-1906959ec036"], "manufacturer_name": ["Cranbury Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (27808-085-01)", "package_ndc": "27808-085-01", "marketing_start_date": "20130531"}], "brand_name": "Dextroamphetamine", "product_id": "27808-085_442f3920-82b4-41ab-b485-24954a2ebddb", "dosage_form": "SOLUTION", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "27808-085", "dea_schedule": "CII", "generic_name": "Dextroamphetamine", "labeler_name": "Cranbury Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dextroamphetamine", "active_ingredients": [{"name": "DEXTROAMPHETAMINE SULFATE", "strength": "5 mg/5mL"}], "application_number": "ANDA203644", "marketing_category": "ANDA", "marketing_start_date": "20130531", "listing_expiration_date": "20261231"}