Ibuprofen and famotidine

Product NDC
0093-8107
11-digit product format
000938107
Labeler code
0093
Product ID
0093-8107_103e496e-b449-4f27-800f-5059465f774a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen and famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA211278
Marketing category
ANDA
Marketing start
2021-12-15
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
0093-8107-98EA - Each0093-810785a94abd-9583-4f25-92f0-db0423cfbac012022-01-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-8107-980009381079890 TABLET, FILM COATED in 1 BOTTLE (0093-8107-98) 2021-12-150000-00-00NoNoCurrent