quillichew er

Generic: methylphenidate hydrochloride

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

Drug Facts

Product Profile

Brand Name quillichew er
Generic Name methylphenidate hydrochloride
Labeler nextwave pharmaceuticals, inc
Dosage Form TABLET, CHEWABLE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 40 mg/1

Manufacturer
NextWave Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 24478-076
Product ID 24478-076_0676036e-ee33-47ed-ac04-f83503ff2771
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA207960
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2016-04-18

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 24478076
Hyphenated Format 24478-076

Supplemental Identifiers

RxCUI
1727443 1727450 1734928 1734930 1734951 1734953
UPC
0324478076016 0324478074012 0324478074029 0324478075019 0324478076023 0324478075026
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 quillichew er (source: ndc)
Generic Name methylphenidate hydrochloride (source: ndc)
Application Number NDA207960 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 100 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-076-01)
source: ndc

Packages (1)

24478-076-01 100 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-076-01)

Ingredients (1)

methylphenidate hydrochloride (40 mg/1)

Linked Drug Pages (1)

QuilliChew ER ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0676036e-ee33-47ed-ac04-f83503ff2771", "openfda": {"upc": ["0324478076016", "0324478074012", "0324478074029", "0324478075019", "0324478076023", "0324478075026"], "unii": ["4B3SC438HI"], "rxcui": ["1727443", "1727450", "1734928", "1734930", "1734951", "1734953"], "spl_set_id": ["defc1205-8e90-4b1e-b862-05e4c35c7364"], "manufacturer_name": ["NextWave Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-076-01)", "package_ndc": "24478-076-01", "marketing_start_date": "20160418"}], "brand_name": "QuilliChew ER", "product_id": "24478-076_0676036e-ee33-47ed-ac04-f83503ff2771", "dosage_form": "TABLET, CHEWABLE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "24478-076", "dea_schedule": "CII", "generic_name": "methylphenidate hydrochloride", "labeler_name": "NextWave Pharmaceuticals, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "QuilliChew ER", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "NDA207960", "marketing_category": "NDA", "marketing_start_date": "20160418", "listing_expiration_date": "20271231"}