xtampza er

Generic: oxycodone

Labeler: collegium pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xtampza er
Generic Name oxycodone
Labeler collegium pharmaceutical, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

oxycodone 18 mg/1

Manufacturer
Collegium Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 24510-120
Product ID 24510-120_fda0989d-9319-4e35-af83-fca1ec66878e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208090
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2016-05-10

Pharmacologic Class

Established (EPC)
opioid agonist [epc]
Mechanism of Action
full opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24510120
Hyphenated Format 24510-120

Supplemental Identifiers

RxCUI
1790527 1790533 1791558 1791560 1791567 1791569 1791574 1791576 1791580 1791582
UPC
0324510140101 0324510115109 0324510130102
UNII
CD35PMG570
NUI
N0000175684 N0000175690

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 xtampza er (source: ndc)
Generic Name oxycodone (source: ndc)
Application Number NDA208090 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 18 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (24510-120-10)
  • 20 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (24510-120-20)
source: ndc

Packages (2)

24510-120-10 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (24510-120-10) 24510-120-20 20 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (24510-120-20)

Ingredients (1)

oxycodone (18 mg/1)

Linked Drug Pages (1)

XTAMPZA ER ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fda0989d-9319-4e35-af83-fca1ec66878e", "openfda": {"nui": ["N0000175684", "N0000175690"], "upc": ["0324510140101", "0324510115109", "0324510130102"], "unii": ["CD35PMG570"], "rxcui": ["1790527", "1790533", "1791558", "1791560", "1791567", "1791569", "1791574", "1791576", "1791580", "1791582"], "spl_set_id": ["b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c"], "pharm_class_epc": ["Opioid Agonist [EPC]"], "pharm_class_moa": ["Full Opioid Agonists [MoA]"], "manufacturer_name": ["Collegium Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (24510-120-10)", "package_ndc": "24510-120-10", "marketing_start_date": "20160510"}, {"sample": false, "description": "20 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (24510-120-20)", "package_ndc": "24510-120-20", "marketing_start_date": "20160510"}], "brand_name": "XTAMPZA ER", "product_id": "24510-120_fda0989d-9319-4e35-af83-fca1ec66878e", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "24510-120", "dea_schedule": "CII", "generic_name": "OXYCODONE", "labeler_name": "Collegium Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "XTAMPZA", "brand_name_suffix": "ER", "active_ingredients": [{"name": "OXYCODONE", "strength": "18 mg/1"}], "application_number": "NDA208090", "marketing_category": "NDA", "marketing_start_date": "20160510", "listing_expiration_date": "20271231"}