NDC 52054-513

DEXEDRINE SPANSULE

Dextroamphetamine Sulfate

DEXEDRINE SPANSULE is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Amedra Pharmaceuticals Llc. The primary component is Dextroamphetamine Sulfate.

• Product ID: 52054-513_6e6c242b-da63-4bd3-86a6-f22e10419291
• NDC: 52054-513
• Product Type: Human Prescription Drug
• Proprietary Name: DEXEDRINE SPANSULE
• Generic Name: Dextroamphetamine Sulfate
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 1976-08-02
• Marketing End Date: 2019-12-01
• Marketing Category: NDA / NDA
• Application Number: NDA017078
• Labeler Name: Amedra Pharmaceuticals LLC
• Substance Name: DEXTROAMPHETAMINE SULFATE
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
• DEA Schedule: CII
• NDC Exclude Flag: N

Packaging

NDC 52054-513-09

1 BOTTLE in 1 CARTON (52054-513-09) > 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

• Marketing Start Date: 1976-08-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52054-513-09 [52054051309]

DEXEDRINE SPANSULE CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA017078
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1976-08-02
• Marketing End Date: 2019-12-01

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROAMPHETAMINE SULFATE	10 mg/1

OpenFDA Data

• SPL SET ID: a37b6ef9-78b4-4b18-8797-ecb583502500
• Manufacturer:
  • Amedra Pharmaceuticals LLC
• UNII:
  • JJ768O327N
• RxNorm Concept Unique ID - RxCUI:
  • 884528
  • 884537
  • 884534
  • 884535
  • 884532
  • 884520
• UPC Code:
  • 0352054513099
  • 0352054514096
  • 0352054512092

Pharmacological Class

• Central Nervous System Stimulant [EPC]
• Central Nervous System Stimulation [PE]

Medicade Reported Pricing

52054051309 DEXEDRINE SPANSULE 10 MG

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "DEXEDRINE SPANSULE" or generic name "Dextroamphetamine Sulfate"

NDC	Brand Name	Generic Name
52054-514	DEXEDRINE SPANSULE	DEXEDRINE SPANSULE
52054-513	DEXEDRINE SPANSULE	DEXEDRINE SPANSULE
52054-512	DEXEDRINE SPANSULE	DEXEDRINE SPANSULE
64896-674	DEXEDRINE SPANSULE	DEXEDRINE SPANSULE
64896-673	DEXEDRINE SPANSULE	DEXEDRINE SPANSULE
64896-675	DEXEDRINE SPANSULE	DEXEDRINE SPANSULE
0115-9927	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate
0115-9928	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate
0115-9929	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate
0406-8958	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate
0406-8959	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate
0406-8960	Dextroamphetamine Sulfate	dextroamphetamine sulfate
0406-8961	Dextroamphetamine Sulfate	dextroamphetamine sulfate
0406-8962	Dextroamphetamine Sulfate	dextroamphetamine sulfate
0555-0952	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate
0555-0953	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate
0115-1702	Dextroamphetamine SulfateExtended-Release	Dextroamphetamine Sulfate
0115-1703	Dextroamphetamine SulfateExtended-Release	Dextroamphetamine Sulfate
0115-1704	Dextroamphetamine SulfateExtended-Release	Dextroamphetamine Sulfate