dexedrine spansule

Generic: dextroamphetamine sulfate

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexedrine spansule
Generic Name dextroamphetamine sulfate
Labeler amneal pharmaceuticals llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

dextroamphetamine sulfate 15 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 64896-675
Product ID 64896-675_d5d5a976-872f-4849-b222-1fb433511511
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA017078
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 1976-08-02

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 64896675
Hyphenated Format 64896-675

Supplemental Identifiers

RxCUI
884520 884528 884532 884534 884535 884537
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 dexedrine spansule (source: ndc)
Generic Name dextroamphetamine sulfate (source: ndc)
Application Number NDA017078 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (64896-675-10) / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
source: ndc

Packages (1)

64896-675-10 1 BOTTLE in 1 CARTON (64896-675-10) / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

Ingredients (1)

dextroamphetamine sulfate (15 mg/1)

Linked Drug Pages (1)

DEXEDRINE SPANSULE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d5d5a976-872f-4849-b222-1fb433511511", "openfda": {"unii": ["JJ768O327N"], "rxcui": ["884520", "884528", "884532", "884534", "884535", "884537"], "spl_set_id": ["cc717b9b-22ea-4c60-a1d4-ee38a40bce78"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (64896-675-10)  / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "64896-675-10", "marketing_start_date": "19760802"}], "brand_name": "DEXEDRINE SPANSULE", "product_id": "64896-675_d5d5a976-872f-4849-b222-1fb433511511", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "64896-675", "dea_schedule": "CII", "generic_name": "dextroamphetamine sulfate", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DEXEDRINE", "brand_name_suffix": "SPANSULE", "active_ingredients": [{"name": "DEXTROAMPHETAMINE SULFATE", "strength": "15 mg/1"}], "application_number": "NDA017078", "marketing_category": "NDA", "marketing_start_date": "19760802", "listing_expiration_date": "20261231"}