dyanavel xr

Generic: amphetamine

Labeler: nextwave pharmaceuticals, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name dyanavel xr
Generic Name amphetamine
Labeler nextwave pharmaceuticals, inc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

amphetamine 5 mg/1

Manufacturer
NextWave Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 24478-106
Product ID 24478-106_32c90701-fe4a-4d5a-b3bb-e9ccf0416ece
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210526
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2021-11-04

Pharmacologic Class

Established (EPC)
central nervous system stimulant [epc]
Physiologic Effect
central nervous system stimulation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24478106
Hyphenated Format 24478-106

Supplemental Identifiers

RxCUI
1720586 1720592 2585460 2585461 2585462 2585465 2585468 2585471 2585473 2585476
UPC
0324478102029 0324478108014 0324478110017 0324478109011
UNII
CK833KGX7E
NUI
N0000175739 N0000175729

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 dyanavel xr (source: ndc)
Generic Name amphetamine (source: ndc)
Application Number NDA210526 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (24478-106-01)
source: ndc

Packages (1)

24478-106-01 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (24478-106-01)

Ingredients (1)

amphetamine (5 mg/1)

Linked Drug Pages (1)

Dyanavel XR, DYANAVEL XR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "32c90701-fe4a-4d5a-b3bb-e9ccf0416ece", "openfda": {"nui": ["N0000175739", "N0000175729"], "upc": ["0324478102029", "0324478108014", "0324478110017", "0324478109011"], "unii": ["CK833KGX7E"], "rxcui": ["1720586", "1720592", "2585460", "2585461", "2585462", "2585465", "2585468", "2585471", "2585473", "2585476"], "spl_set_id": ["ae304b29-0b40-40ec-ad0d-76b742d4a9b9"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]"], "pharm_class_epc": ["Central Nervous System Stimulant [EPC]"], "manufacturer_name": ["NextWave Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (24478-106-01)", "package_ndc": "24478-106-01", "marketing_start_date": "20220801"}], "brand_name": "DYANAVEL XR", "product_id": "24478-106_32c90701-fe4a-4d5a-b3bb-e9ccf0416ece", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "24478-106", "dea_schedule": "CII", "generic_name": "amphetamine", "labeler_name": "NextWave Pharmaceuticals, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DYANAVEL XR", "active_ingredients": [{"name": "AMPHETAMINE", "strength": "5 mg/1"}], "application_number": "NDA210526", "marketing_category": "NDA", "marketing_start_date": "20211104", "listing_expiration_date": "20271231"}