Sulfasalazine

Product NDC
71610-577
11-digit product format
716100577
Labeler code
71610
Product ID
71610-577_0df8f6fc-4e63-401a-b8c5-360f91006687
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfasalazine
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA085828
Marketing category
ANDA
Marketing start
1982-10-01
Marketing end
0000-00-00
Substance
SULFASALAZINE
Active strength
500 mg/1
Pharmacologic classes
Aminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-577-70EA - Each71610-577bd616ddd-03d0-4f73-a2a4-1677276bbb0512021-09-07
71610-577-80EA - Each71610-57778dbc945-d204-4531-b12a-7878ec213eef12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-577SULFASALAZINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20210806_f37e45be-c3b2-4b8a-a262-d8fc35e4510c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-577-7071610057770120 TABLET in 1 BOTTLE, PLASTIC (71610-577-70) 120 tablet2021-07-010000-00-00NoNoCurrent
71610-577-8071610057780180 TABLET in 1 BOTTLE, PLASTIC (71610-577-80) 180 tablet2021-07-010000-00-00NoNoCurrent