NDC 71335-0447

ropinirole

Ropinirole

ropinirole is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Ropinirole Hydrochloride.

• Product ID: 71335-0447_cbc3905f-e2bc-4eaa-8166-2774d6d11390
• NDC: 71335-0447
• Product Type: Human Prescription Drug
• Proprietary Name: ropinirole
• Generic Name: Ropinirole
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2010-02-25
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090135
• Labeler Name: Bryant Ranch Prepack
• Substance Name: ROPINIROLE HYDROCHLORIDE
• Active Ingredient Strength: 1 mg/1
• Pharm Classes: Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 71335-0447-3

90 TABLET, FILM COATED in 1 BOTTLE (71335-0447-3)

• Marketing Start Date: 2016-09-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71335-0447-1 [71335044701]

ropinirole TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA090135
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-09-15
• Marketing End Date: 2019-05-31

NDC 71335-0447-4 [71335044704]

ropinirole TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA090135
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-09-15
• Marketing End Date: 2019-05-31

NDC 71335-0447-3 [71335044703]

ropinirole TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA090135
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-09-15
• Marketing End Date: 2019-05-31

NDC 71335-0447-2 [71335044702]

ropinirole TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA090135
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-09-15
• Marketing End Date: 2019-05-31

Drug Details

Active Ingredients

Ingredient	Strength
ROPINIROLE HYDROCHLORIDE	1 mg/1

OpenFDA Data

• SPL SET ID: cc80be71-8856-42f6-ab76-6090049342a5
• Manufacturer:
  • Bryant Ranch Prepack
• UNII:
  • D7ZD41RZI9
• RxNorm Concept Unique ID - RxCUI:
  • 314208
  • 312845
  • 312846
  • 312847

Pharmacological Class

• 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