NDC 43353-198 Ropinirole Hydrochloride
View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 43353 - Aphena Pharma Solutions - Tennessee, Llc
- 43353-198 - Ropinirole Hydrochloride
Product Characteristics
YELLOW (C48330 - YELLOW)
GREEN (C48329 - GREEN)
PINK (C48328 - PINK)
973;HH
974;HH
975;HH
Product Packages
NDC Code 43353-198-09
Package Description: 9000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Details
What is NDC 43353-198?
What are the uses for Ropinirole Hydrochloride?
Which are Ropinirole Hydrochloride UNII Codes?
The UNII codes for the active ingredients in this product are:
- ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9)
- ROPINIROLE (UNII: 030PYR8953) (Active Moiety)
Which are Ropinirole Hydrochloride 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:
- HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)
- LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
- CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
- CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
- POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
- POLYVINYL ALCOHOL (UNII: 532B59J990)
- TALC (UNII: 7SEV7J4R1U)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
- FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
- FERRIC OXIDE RED (UNII: 1K09F3G675)
What is the NDC to RxNorm Crosswalk for Ropinirole Hydrochloride?
- RxCUI: 312845 - rOPINIRole HCl 0.25 MG Oral Tablet
- RxCUI: 312845 - ropinirole 0.25 MG Oral Tablet
- RxCUI: 312845 - ropinirole 0.25 MG (as ropinirole hydrochloride) Oral Tablet
- RxCUI: 312846 - rOPINIRole HCl 0.5 MG Oral Tablet
- RxCUI: 312846 - ropinirole 0.5 MG Oral Tablet
* Please review the disclaimer below.
Patient Education
Ropinirole
Ropinirole is used alone or with other medications to treat the symptoms of Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance), including shaking of parts of the body, stiffness, slowed movements, and problems with balance. Ropinirole is also used to treat restless legs syndrome (RLS or Ekbom syndrome; a condition that causes discomfort in the legs and a strong urge to move the legs, especially at night and when sitting or lying down). Ropinirole is in a class of medications called dopamine agonists. It works by acting in place of dopamine, a natural substance in the brain that is needed to control movement.
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* Please review the disclaimer below.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[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".