Ibuprofen and Famotidine

Product NDC
70748-312
11-digit product format
707480312
Labeler code
70748
Product ID
70748-312_d0532dfa-e690-464f-be38-fce09adce154
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen and Famotidine
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
NDA022519
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2021-09-14
Marketing end
0000-00-00
Substance
FAMOTIDINE; IBUPROFEN
Active strength
27 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70748-312-09EA - Each70748-312779ff88c-6dac-4da7-934a-e093f4ebdabb12021-10-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70748-312-097074803120990 TABLET, COATED in 1 BOTTLE (70748-312-09) 2021-09-010000-00-00NoNoCurrent