Spironolactone

Product NDC
55700-953
11-digit product format
557000953
Labeler code
55700
Product ID
55700-953_21478456-112d-4767-a9ed-7135a9084cac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA203512
Marketing category
ANDA
Marketing start
2021-12-15
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
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
55700-953-30EA - Each55700-9538cb7ea59-57eb-4be9-8fb4-7ac1d203e63612022-03-09
55700-953-90EA - Each55700-95359349470-efba-49bd-a2d2-af437b37bc5512022-03-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-953-305570009533030 TABLET, FILM COATED in 1 BOTTLE (55700-953-30) 2021-12-150000-00-00NoNoCurrent
55700-953-905570009539090 TABLET, FILM COATED in 1 BOTTLE (55700-953-90) 2021-12-150000-00-00NoNoCurrent