Ropinirole

Product NDC: 0054-0117
11-digit product format: 000540117
Labeler code: 0054
Product ID: 0054-0117_89b0f8ed-b89f-461b-a0d7-6a52a82aa57d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rOPINIRole
Dosage form: TABLET
Route: ORAL
Labeler: West-Ward Pharmaceuticals Corp.
Application: ANDA077852
Marketing category: ANDA
Marketing start: 2008-05-05
Marketing end: 2021-04-09
Substance: ROPINIROLE HYDROCHLORIDE
Active strength: 1 mg/1
Pharmacologic classes: Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dc920868-8845-b908-7ca8-0dee3e345af5	Product name	2	20230123
e24bc1b4-1e16-908e-3d09-29da3ca2fb1f	Product name	2	20170517

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-0117-25	EA - Each	0054-0117	1be7f45b-ed94-4521-ba0b-8480fe17e054	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ROPINIROLE HYDROCHLORIDE	ACTIVE INGREDIENT	D7ZD41RZI9	ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]	2
ROPINIROLE	ACTIVE MOIETY	030PYR8953	ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D7ZD41RZI9	ROPINIROLE HYDROCHLORIDE	91374-20-8	ROPINIROLE HYDROCHLORIDE
030PYR8953	ROPINIROLE	91374-21-9	rOPINIRole

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312846	rOPINIRole HCl 0.5 MG Oral Tablet	PSN	366a173b-d6a0-4c96-8539-dad363159d98	3
312846	ropinirole 0.5 MG Oral Tablet	SCD	366a173b-d6a0-4c96-8539-dad363159d98	3
312846	ropinirole 0.5 MG (as ropinirole hydrochloride) Oral Tablet	SY	366a173b-d6a0-4c96-8539-dad363159d98	3

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-0117-25	00054011725	100 TABLET in 1 BOTTLE (0054-0117-25)	100 tablet	2008-05-05	2021-04-09	No	No	Current