NDC 10135-677

Ropinirole

Ropinirole

Ropinirole is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Marlex Pharmaceuticals Inc. The primary component is Ropinirole Hydrochloride.

• Product ID: 10135-677_bb25d2e3-7586-a333-e053-2a95a90a48d1
• NDC: 10135-677
• Product Type: Human Prescription Drug
• Proprietary Name: Ropinirole
• Generic Name: Ropinirole
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-03-15
• Marketing Category: ANDA / ANDA
• Application Number: ANDA079165
• Labeler Name: Marlex Pharmaceuticals Inc
• Substance Name: ROPINIROLE HYDROCHLORIDE
• Active Ingredient Strength: 3 mg/1
• Pharm Classes: Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 10135-677-01

100 TABLET, FILM COATED in 1 BOTTLE (10135-677-01)

• Marketing Start Date: 2019-03-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10135-677-01 [10135067701]

Ropinirole TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA079165
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-03-15

Drug Details

Active Ingredients

Ingredient	Strength
ROPINIROLE HYDROCHLORIDE	3 mg/1

OpenFDA Data

• SPL SET ID: 35d90f6f-3116-4afa-be2d-b65c160e8ab3
• Manufacturer:
  • Marlex Pharmaceuticals Inc
• UNII:
  • D7ZD41RZI9
• RxNorm Concept Unique ID - RxCUI:
  • 312845
  • 312846
  • 312847
  • 314208
  • 312849
  • 562704
  • 283858
• UPC Code:
  • 0310135674015
  • 0310135676019
  • 0310135673018
  • 0310135675012
  • 0310135678013
  • 0310135679010
  • 0310135677016

Pharmacological Class

• Dopamine Agonists [MoA]
• Nonergot Dopamine Agonist [EPC]
• Dopamine Agonists [MoA]
• Nonergot Dopamine Agonist [EPC]

NDC Crossover Matching brand name "Ropinirole" or generic name "Ropinirole"

NDC	Brand Name	Generic Name
0054-0116	Ropinirole	rOPINIRole
0054-0117	Ropinirole	rOPINIRole
0054-0118	Ropinirole	rOPINIRole
0054-0119	Ropinirole	rOPINIRole
0054-0120	Ropinirole	rOPINIRole
0054-0121	Ropinirole	rOPINIRole
0054-0122	Ropinirole	rOPINIRole
0228-3640	Ropinirole	Ropinirole
0228-3658	Ropinirole	Ropinirole
0228-3659	Ropinirole	Ropinirole
0228-3660	Ropinirole	Ropinirole
0228-3661	Ropinirole	Ropinirole
0378-5501	Ropinirole	ropinirole
0378-5502	Ropinirole	ropinirole
68151-4073	Ropinirole	Ropinirole
68151-4071	Ropinirole	Ropinirole
68151-4072	Ropinirole	Ropinirole
68258-7163	ropinirole	ropinirole
68462-259	ropinirole	ropinirole
68462-253	ropinirole	ropinirole
68462-255	ropinirole	ropinirole
68462-256	ropinirole	ropinirole
68462-258	ropinirole	ropinirole
68462-254	ropinirole	ropinirole
68462-257	ropinirole	ropinirole
71335-0064	ropinirole	ropinirole
71335-0560	ropinirole	ropinirole
71335-0447	ropinirole	ropinirole
71335-0631	ropinirole	ropinirole
0781-5786	ropinirole	ropinirole
0781-5782	ropinirole	ropinirole
0781-5784	ropinirole	ropinirole
0781-5780	ropinirole	ropinirole
0781-5788	ropinirole	ropinirole
10135-673	Ropinirole	Ropinirole
10135-674	Ropinirole	Ropinirole
10135-675	Ropinirole	Ropinirole
10135-679	Ropinirole	Ropinirole
10135-678	Ropinirole	Ropinirole
10135-677	Ropinirole	Ropinirole
10135-676	Ropinirole	Ropinirole
13811-639	Ropinirole	Ropinirole
13811-643	Ropinirole	Ropinirole
13811-641	Ropinirole	Ropinirole
13811-640	Ropinirole	Ropinirole
13811-642	Ropinirole	Ropinirole
16729-235	ropinirole	ropinirole
16729-234	ropinirole	ropinirole
16729-233	ropinirole	ropinirole
16729-237	ropinirole	ropinirole