Dyanavel XR

Generic: amphetamine

Labeler: NextWave Pharmaceuticals, Inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Active

Drug Facts

Product Profile

Brand Name Dyanavel XR
Generic Name amphetamine
Labeler NextWave Pharmaceuticals, Inc
Dosage Form SUSPENSION, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

AMPHETAMINE 2.5 mg/mL

Identifiers & Regulatory

Product NDC 24478-102
Product ID 24478-102_5c4d1b8b-6b4a-4fc7-8f8e-37f33c9b6ad7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208147
DEA Schedule CII
Listing Expiration 2027-12-31
Marketing Start 2015-10-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24478102
Hyphenated Format 24478-102

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 NDA208147 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (24478-102-01) / 464 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (24478-102-02) / 60 mL in 1 BOTTLE
source: ndc

Packages (2)

24478-102-01 1 BOTTLE in 1 CARTON (24478-102-01) / 464 mL in 1 BOTTLE 24478-102-02 1 BOTTLE in 1 CARTON (24478-102-02) / 60 mL in 1 BOTTLE

Ingredients (1)

AMPHETAMINE (2.5 mg/mL)

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": "5c4d1b8b-6b4a-4fc7-8f8e-37f33c9b6ad7", "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": "1 BOTTLE in 1 CARTON (24478-102-01)  / 464 mL in 1 BOTTLE", "package_ndc": "24478-102-01", "marketing_start_date": "20220725"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (24478-102-02)  / 60 mL in 1 BOTTLE", "package_ndc": "24478-102-02", "marketing_start_date": "20260209"}], "brand_name": "Dyanavel XR", "product_id": "24478-102_5c4d1b8b-6b4a-4fc7-8f8e-37f33c9b6ad7", "dosage_form": "SUSPENSION, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "24478-102", "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": "2.5 mg/mL"}], "application_number": "NDA208147", "marketing_category": "NDA", "marketing_start_date": "20151001", "listing_expiration_date": "20271231"}