Diclofenac Sodium and Misoprostol

Product NDC: 70518-3261
11-digit product format: 705183261
Labeler code: 70518
Product ID: 70518-3261_d070ad41-4ddb-4e2f-e053-2a95a90ada41
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium and Misoprostol
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA201089
Marketing category: ANDA
Marketing start: 2021-11-01
Marketing end: 0000-00-00
Substance: DICLOFENAC SODIUM; MISOPROSTOL
Active strength: 50 mg/1; ug/1
Pharmacologic classes: Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-3261-0	2023-03-23	C162847	48780-1	f386c649-e25d-0266-e053-dadaa90a7c1a	11027560-ba8e-4754-ba0e-a7511b6a3a1f
70518-3261-0	2023-01-30	C162847	48780-1	f386c649-e25d-0266-e053-dadaa90a7c1a	11027560-ba8e-4754-ba0e-a7511b6a3a1f

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QTG126297Q	DICLOFENAC SODIUM	15307-79-6	DICLOFENAC SODIUM
0E43V0BB57	MISOPROSTOL	59122-46-2	MISOPROSTOL

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3261-0	70518326100	60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-3261-0)	2021-11-01	0000-00-00	No	No	Current