Ropinirole Hydrochloride

Product NDC: 68258-7162
11-digit product format: 682587162
Labeler code: 68258
Product ID: 68258-7162_ec4d59ce-00e6-4dcd-a59b-ff74d334eec4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ropinirole Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Dispensing Solutions, Inc.
Application: ANDA090429
Marketing category: ANDA
Marketing start: 2009-09-18
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: 2017-12-31
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
68258-7162-3	2019-11-27	C162847	48780-1	9855d018-d2e9-cd31-e053-dbdaa90ab51a	Ropinirole Hydrochloride Tablets Rx only PRESCRIBING INFORMATION Patient Information Included

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68258-7162-3	Ropinirole Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30		2

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ROPINIROLE HYDROCHLORIDE	ACTIVE INGREDIENT	D7ZD41RZI9	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
ROPINIROLE	ACTIVE MOIETY	030PYR8953	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68258-7162	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2	Legacy NDC, 1 package rows	20130814_c1c74e92-c34f-4ab7-b541-5ac0b738c846.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D7ZD41RZI9	ROPINIROLE HYDROCHLORIDE	91374-20-8	ROPINIROLE HYDROCHLORIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312845	rOPINIRole HCl 0.25 MG Oral Tablet	PSN	c1c74e92-c34f-4ab7-b541-5ac0b738c846	2
312845	ropinirole 0.25 MG Oral Tablet	SCD	c1c74e92-c34f-4ab7-b541-5ac0b738c846	2
312845	ropinirole 0.25 MG (as ropinirole hydrochloride) Oral Tablet	SY	c1c74e92-c34f-4ab7-b541-5ac0b738c846	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68258-7162-3	68258716203	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ropinirole Hydrochloride	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2013-08-14	Human Prescription Drug Label	2