Sumatriptan and Naproxen Sodium

Product NDC
0378-8755
11-digit product format
003788755
Labeler code
0378
Product ID
0378-8755_b9954dce-aec2-4429-9557-89ad3683ea4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sumatriptan and naproxen sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA090872
Marketing category
ANDA
Marketing start
2018-09-04
Marketing end
2021-12-31
Substance
SUMATRIPTAN SUCCINATE; NAPROXEN SODIUM
Active strength
85 mg/1; mg/1
Pharmacologic classes
Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-8755-59EA - Each0378-87556423d894-4589-4080-a786-120f980bc32612018-10-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-8755-59003788755599 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-8755-59) 2018-09-040000-00-00NoNoCurrent