quillivant xr

Generic: methylphenidate hydrochloride

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

Drug Facts

Product Profile

Brand Name quillivant xr
Generic Name methylphenidate hydrochloride
Labeler nextwave pharmaceuticals, inc
Dosage Form SUSPENSION, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 750 mg/150mL

Manufacturer
NextWave Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 24478-323
Product ID 24478-323_803664c3-d092-49ce-bdff-ad44547c3a70
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202100
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2012-10-01

Pharmacologic Class

Classes
central nervous system stimulant [epc] central nervous system stimulation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24478323
Hyphenated Format 24478-323

Supplemental Identifiers

RxCUI
1312583 1312589
UNII
4B3SC438HI

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 quillivant xr (source: ndc)
Generic Name methylphenidate hydrochloride (source: ndc)
Application Number NDA202100 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/150mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (24478-323-05) / 150 mL in 1 BOTTLE
source: ndc

Packages (1)

24478-323-05 1 BOTTLE in 1 CARTON (24478-323-05) / 150 mL in 1 BOTTLE

Ingredients (1)

methylphenidate hydrochloride (750 mg/150mL)

Linked Drug Pages (1)

Quillivant XR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "803664c3-d092-49ce-bdff-ad44547c3a70", "openfda": {"unii": ["4B3SC438HI"], "rxcui": ["1312583", "1312589"], "spl_set_id": ["c2dc2109-44a6-4797-b04e-18761dd9d45a"], "manufacturer_name": ["NextWave Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (24478-323-05)  / 150 mL in 1 BOTTLE", "package_ndc": "24478-323-05", "marketing_start_date": "20121001"}], "brand_name": "Quillivant XR", "product_id": "24478-323_803664c3-d092-49ce-bdff-ad44547c3a70", "dosage_form": "SUSPENSION, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "24478-323", "dea_schedule": "CII", "generic_name": "methylphenidate hydrochloride", "labeler_name": "NextWave Pharmaceuticals, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quillivant", "brand_name_suffix": "XR", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "750 mg/150mL"}], "application_number": "NDA202100", "marketing_category": "NDA", "marketing_start_date": "20121001", "listing_expiration_date": "20261231"}