NDC 24338-035

Evekeo ODT

Amphetamine Sulfate

Evekeo ODT is a Oral Tablet, Orally Disintegrating in the Human Prescription Drug category. It is labeled and distributed by Arbor Pharmaceuticals. The primary component is Amphetamine Sulfate.

• Product ID: 24338-035_1f414451-be36-4ee8-8494-25554fe17b63
• NDC: 24338-035
• Product Type: Human Prescription Drug
• Proprietary Name: Evekeo ODT
• Generic Name: Amphetamine Sulfate
• Dosage Form: Tablet, Orally Disintegrating
• Route of Administration: ORAL
• Marketing Start Date: 2019-06-28
• Marketing Category: NDA / NDA
• Application Number: NDA209905
• Labeler Name: Arbor Pharmaceuticals
• Substance Name: AMPHETAMINE SULFATE
• Active Ingredient Strength: 15 mg/1
• Pharm Classes: Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 24338-035-01

1 CASE in 1 CARTON (24338-035-01) > 1 BLISTER PACK in 1 CASE (24338-035-30) > 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

• Marketing Start Date: 2019-06-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 24338-035-01 [24338003501]

Evekeo ODT TABLET, ORALLY DISINTEGRATING

• Marketing Category: NDA
• Application Number: NDA209905
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-06-28

NDC 24338-035-30 [24338003530]

Evekeo ODT TABLET, ORALLY DISINTEGRATING

• Marketing Category: NDA
• Application Number: NDA209905
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-06-28

Drug Details

Active Ingredients

Ingredient	Strength
AMPHETAMINE SULFATE	15 mg/1

OpenFDA Data

• SPL SET ID: 1e25f905-6c0b-4b19-a3b6-b2a386afa1c3
• Manufacturer:
  • Arbor Pharmaceuticals
• UNII:
  • 6DPV8NK46S
• RxNorm Concept Unique ID - RxCUI:
  • 2118898
  • 2175796
  • 2118900
  • 2118895
  • 2118896
  • 2175891
  • 2175893
  • 2175894

Pharmacological Class

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

NDC Crossover Matching brand name "Evekeo ODT" or generic name "Amphetamine Sulfate"

NDC	Brand Name	Generic Name
24338-031	Evekeo ODT	AMPHETAMINE SULFATE
24338-033	Evekeo ODT	AMPHETAMINE SULFATE
24338-035	Evekeo ODT	AMPHETAMINE SULFATE
24338-037	Evekeo ODT	AMPHETAMINE SULFATE
0406-1219	Amphetamine Sulfate	Amphetamine Sulfate
0406-1220	Amphetamine Sulfate	Amphetamine Sulfate
0527-2524	AMPHETAMINE SULFATE	amphetamine sulfate
0527-2525	AMPHETAMINE SULFATE	amphetamine sulfate
13107-259	Amphetamine Sulfate	Amphetamine Sulfate
13107-260	Amphetamine Sulfate	Amphetamine Sulfate
24338-022	Evekeo	Amphetamine Sulfate
24338-026	Evekeo	Amphetamine Sulfate