NDC 70165-010

Adzenys XR-ODT

Amphetamine

Adzenys XR-ODT is a Oral Tablet, Orally Disintegrating in the Human Prescription Drug category. It is labeled and distributed by Neos Therapeutics Brands, Llc. The primary component is Amphetamine.

• Product ID: 70165-010_c3cb48b4-d629-5c54-e053-2a95a90ab3d8
• NDC: 70165-010
• Product Type: Human Prescription Drug
• Proprietary Name: Adzenys XR-ODT
• Generic Name: Amphetamine
• Dosage Form: Tablet, Orally Disintegrating
• Route of Administration: ORAL
• Marketing Start Date: 2016-02-16
• Marketing Category: NDA / NDA
• Application Number: NDA204326
• Labeler Name: Neos Therapeutics Brands, LLC
• Substance Name: AMPHETAMINE
• Active Ingredient Strength: 6 mg/1
• Pharm Classes: Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 70165-010-30

30 BLISTER PACK in 1 CARTON (70165-010-30) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

• Marketing Start Date: 2016-02-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70165-010-30 [70165001030]

Adzenys XR-ODT TABLET, ORALLY DISINTEGRATING

• Marketing Category: NDA
• Application Number: NDA204326
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-02-16

Drug Details

Active Ingredients

Ingredient	Strength
AMPHETAMINE	6.3 mg/1

OpenFDA Data

• SPL SET ID: c1179269-00b5-48ea-972d-31e614e99b7e
• Manufacturer:
  • Neos Therapeutics, LP
• UNII:
  • CK833KGX7E
• RxNorm Concept Unique ID - RxCUI:
  • 1739839
  • 1739837
  • 1739803
  • 1739813
  • 1739815
  • 1739833
  • 1739825
  • 1739819
  • 1739809
  • 1739831
  • 1739821
  • 1739827

Pharmacological Class

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

Medicade Reported Pricing

70165010030 COTEMPLA XR-ODT 8.6 MG TABLET

Pricing Unit: EA | Drug Type:

70165001030 ADZENYS XR-ODT 6.3 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Adzenys XR-ODT" or generic name "Amphetamine"

NDC	Brand Name	Generic Name
70165-005	Adzenys XR-ODT	Amphetamine
70165-010	Adzenys XR-ODT	Amphetamine
70165-025	Adzenys XR-ODT	Adzenys XR-ODT
70165-020	Adzenys XR-ODT	Adzenys XR-ODT
70165-030	Adzenys XR-ODT	Adzenys XR-ODT
70165-015	Adzenys XR-ODT	Adzenys XR-ODT
70165-003	Adzenys ER	Amphetamine
66993-360	Amphetamine Extended-Release Oral Suspension	Amphetamine
50742-652	Amphetamine Sulfate	Amphetamine
69238-1563	Amphetamine Sulfate	Amphetamine
69238-1564	Amphetamine Sulfate	Amphetamine
69452-227	Amphetamine Sulfate	Amphetamine
69452-228	Amphetamine Sulfate	Amphetamine
24478-102	Dyanavel XR	amphetamine
24478-106	DYANAVEL XR	amphetamine
24478-108	DYANAVEL XR	amphetamine
24478-109	DYANAVEL XR	amphetamine
24478-110	DYANAVEL XR	amphetamine
27808-102	Dyanavel XR	amphetamine
27808-106	DYANAVEL XR	amphetamine
27808-108	DYANAVEL XR	amphetamine
27808-109	DYANAVEL XR	amphetamine
27808-110	DYANAVEL XR	amphetamine