nucynta er

Generic: tapentadol hydrochloride

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

Drug Facts

Product Profile

Brand Name nucynta er
Generic Name tapentadol hydrochloride
Labeler collegium pharmaceutical, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

tapentadol hydrochloride 50 mg/1

Manufacturer
Collegium Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 24510-058
Product ID 24510-058_2d370c0d-8d66-446f-be46-ed92e0f1cf6b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA200533
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2019-04-19

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24510058
Hyphenated Format 24510-058

Supplemental Identifiers

RxCUI
1148797 1148800 1148803 1148807 1148809 1149367 1149370 1149373 1149376 1149378
UPC
0324510058604 0324510116601 0324510174601 0324510232608 0324510291605
UNII
71204KII53

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 nucynta er (source: ndc)
Generic Name tapentadol hydrochloride (source: ndc)
Application Number NDA200533 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (24510-058-01) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24510-058-60)
source: ndc

Packages (2)

24510-058-01 10 BLISTER PACK in 1 CARTON (24510-058-01) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 24510-058-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24510-058-60)

Ingredients (1)

tapentadol hydrochloride (50 mg/1)

Linked Drug Pages (1)

Nucynta ER ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2d370c0d-8d66-446f-be46-ed92e0f1cf6b", "openfda": {"upc": ["0324510058604", "0324510116601", "0324510174601", "0324510232608", "0324510291605"], "unii": ["71204KII53"], "rxcui": ["1148797", "1148800", "1148803", "1148807", "1148809", "1149367", "1149370", "1149373", "1149376", "1149378"], "spl_set_id": ["c3d04d70-0155-4147-9ce4-a3b1fad4b373"], "manufacturer_name": ["Collegium Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (24510-058-01)  / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "24510-058-01", "marketing_start_date": "20190419"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24510-058-60)", "package_ndc": "24510-058-60", "marketing_start_date": "20190419"}], "brand_name": "Nucynta ER", "product_id": "24510-058_2d370c0d-8d66-446f-be46-ed92e0f1cf6b", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "24510-058", "dea_schedule": "CII", "generic_name": "tapentadol hydrochloride", "labeler_name": "Collegium Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nucynta", "brand_name_suffix": "ER", "active_ingredients": [{"name": "TAPENTADOL HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "NDA200533", "marketing_category": "NDA", "marketing_start_date": "20190419", "listing_expiration_date": "20271231"}