Ropinirole

Product NDC: 68151-4071
11-digit product format: 681514071
Labeler code: 68151
Product ID: 68151-4071_45e703c4-75ec-478f-bf14-7e7e60c0f9f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rOPINIRole
Dosage form: TABLET
Route: ORAL
Labeler: Carilion Materials Management
Application: ANDA077852
Marketing category: ANDA
Marketing start: 2008-05-05
Marketing end: 0000-00-00
Substance: ROPINIROLE HYDROCHLORIDE
Active strength: 0 mg/1
Pharmacologic classes: Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68151-4071-2	2020-01-31	C162847	48780-1	9d75b9cf-ec4e-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use rOPINIRole Tablets USP safely and effectively. See full prescribing information for rOPINIRole Tablets USP. rOPINIRole Tablets USP, for oral use Initial U.S. Approval: 1997

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68151-4071-2	Ropinirole	1 in 1 PACKAGE	TABLET	1		5

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

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68151-4071	ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]	5	Legacy NDC, 1 package rows	20171229_417964dc-94c1-475e-b954-9d3e6fcba0e0.zip

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
312845	rOPINIRole HCl 0.25 MG Oral Tablet	PSN	417964dc-94c1-475e-b954-9d3e6fcba0e0	5
312845	ropinirole 0.25 MG Oral Tablet	SCD	417964dc-94c1-475e-b954-9d3e6fcba0e0	5
312845	ropinirole 0.25 MG (as ropinirole hydrochloride) Oral Tablet	SY	417964dc-94c1-475e-b954-9d3e6fcba0e0	5

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68151-4071-2	68151407102	1 in 1 PACKAGE	Historical