Warfarin Sodium

Product NDC: 70518-2381
11-digit product format: 705182381
Labeler code: 70518
Product ID: 70518-2381_4dc67a0e-7341-0e58-e063-6294a90a1c6a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Warfarin
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA202202
Marketing category: ANDA
Marketing start: 2019-10-23
Substance: WARFARIN SODIUM
Active strength: 2 mg/1
Pharmacologic classes: Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
WARFARIN SODIUM	2 mg/1

Field, Values table
Field	Values
Unii	6153CWM0CL
Rxcui	855302

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
abcfe2f4-1eca-fdc3-341b-b8134a1aec1f	Product name	1	20140508

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-2381-0	2023-03-09	C162847	48780-1	f386c649-fb54-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets (crystalline), for oral use Initial U.S. Approval: 1954
70518-2381-0	2023-01-30	C162847	48780-1	f386c649-fb54-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets (crystalline), for oral use Initial U.S. Approval: 1954

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-2381-0	Warfarin Sodium	100 in 1 BOX	TABLET	100		6
70518-2381-1	Warfarin Sodium	1 in 1 POUCH	TABLET	1		6

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6153CWM0CL	WARFARIN SODIUM	129-06-6	WARFARIN SODIUM
5Q7ZVV76EI	WARFARIN	81-81-2	Warfarin

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855302	warfarin sodium 2 MG Oral Tablet	PSN	2cbcc99d-9107-4d39-a1e9-e19305de8b5d	6
855302	warfarin sodium 2 MG Oral Tablet	SCD	2cbcc99d-9107-4d39-a1e9-e19305de8b5d	6

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2381-0	70518238100	100 POUCH in 1 BOX (70518-2381-0) / 1 TABLET in 1 POUCH (70518-2381-1)	100 pouch	2019-10-23	0000-00-00	No	No	Current
70518-2381-1	70518238101	1 in 1 POUCH						Historical