Spironolactone

Product NDC
0615-8178
11-digit product format
006158178
Labeler code
0615
Product ID
0615-8178_ec30bfb1-a855-4a0d-9ee4-31ab6dc8ca4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, Inc dba Vangard Labs
Application
ANDA203512
Marketing category
ANDA
Marketing start
2017-06-02
Marketing end
0000-00-00
Substance
SPIRONOLACTONE
Active strength
25 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8178-050061581780515 TABLET, FILM COATED in 1 BLISTER PACK (0615-8178-05) 2017-06-020000-00-00NoNoCurrent
0615-8178-30006158178306 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8178-30) > 5 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack2017-06-020000-00-00NoNoCurrent
0615-8178-390061581783930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8178-39) 2017-06-020000-00-00NoNoCurrent