NALFON

Product NDC
42195-688
11-digit product format
421950688
Labeler code
42195
Product ID
42195-688_f0305a11-4495-e237-e053-2995a90ad12e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenoprofen Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Xspire Pharma, LLC
Application
ANDA072267
Marketing category
ANDA
Marketing start
2018-09-24
Marketing end
0000-00-00
Substance
FENOPROFEN CALCIUM
Active strength
600 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42195-688-102025-04-21C16284748780-12cef2736-a081-d83d-e063-dadaa90ab31ff6f4b654-082a-45ba-9924-41ee9667297a
42195-688-102025-01-30C16284748780-12cef2736-a081-d83d-e063-dadaa90ab31ff6f4b654-082a-45ba-9924-41ee9667297a

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42195-688-10EA - Each42195-6881db321e9-c257-4e5b-bb86-0219a26c152912018-11-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42195-688-1042195068810100 TABLET, FILM COATED in 1 BOTTLE (42195-688-10) 2018-09-240000-00-00NoNoCurrent