NDC 24510-291 Nucynta ER
Tapentadol Hydrochloride Tablet, Film Coated, Extended Release Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 24510 - Collegium Pharmaceutical, Inc.
- 24510-291 - Nucynta
Product Characteristics
BLUE (C48333 - LIGHT BLUE)
BLUE (C48333 - BLUE GREEN)
BLUE (C48333)
BLUE (C48333 - DARK BLUE)
21 MM
OMJ;100
OMJ;150
OMJ;200
OMJ;250
Product Packages
NDC Code 24510-291-01
Package Description: 10 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
NDC Code 24510-291-60
Package Description: 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Price per Unit: $40.18915 per EA
Product Details
What is NDC 24510-291?
What are the uses for Nucynta ER?
What are Nucynta ER Active Ingredients?
- TAPENTADOL HYDROCHLORIDE 250 mg/1 - An opioid analgesic, MU OPIOID RECEPTOR agonist, and noradrenaline reuptake inhibitor that is used in the treatment of moderate to severe pain, and of pain associated with DIABETIC NEUROPATHIES.
Which are Nucynta ER UNII Codes?
The UNII codes for the active ingredients in this product are:
- TAPENTADOL HYDROCHLORIDE (UNII: 71204KII53)
- TAPENTADOL (UNII: H8A007M585) (Active Moiety)
Which are Nucynta ER Inactive Ingredients UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
- HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
- .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
- POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- TALC (UNII: 7SEV7J4R1U)
- SHELLAC (UNII: 46N107B71O)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- FERROSOFERRIC OXIDE (UNII: XM0M87F357)
- FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
- ALUMINUM OXIDE (UNII: LMI26O6933)
- FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
What is the NDC to RxNorm Crosswalk for Nucynta ER?
- RxCUI: 1148797 - tapentadol 100 MG 12HR Extended Release Oral Tablet
- RxCUI: 1148797 - 12 HR tapentadol 100 MG Extended Release Oral Tablet
- RxCUI: 1148800 - tapentadol 150 MG 12HR Extended Release Oral Tablet
- RxCUI: 1148800 - 12 HR tapentadol 150 MG Extended Release Oral Tablet
- RxCUI: 1148803 - tapentadol 200 MG 12HR Extended Release Oral Tablet
Which are the Pharmacologic Classes for Nucynta ER?
* Please review the disclaimer below.
Patient Education
Tapentadol
Tapentadol tablets are used to treat moderate to severe acute pain (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed). Tapentadol extended-release tablets are used to treat severe neuropathic pain (pain caused by nerve damage) in people who have diabetes. Tapentadol extended-release tablets are only used to treat people who are expected to need medication around-the-clock to relieve pain that cannot be controlled by the use of other pain medications. Tapentadol is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.
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* Please review the disclaimer below.
[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
[7] What is the Drug Enforcement Administration (DEA) CII Schedule? - This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.
[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.
[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.
[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".