Spironolactone

Product NDC
16714-637
11-digit product format
167140637
Labeler code
16714
Product ID
16714-637_ee4b013a-434e-77ae-e053-2a95a90a1c6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA203512
Marketing category
ANDA
Marketing start
2022-11-18
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-637-0116714063701100 TABLET, FILM COATED in 1 BOTTLE (16714-637-01) 2017-06-020000-00-00NoNoCurrent
16714-637-0216714063702500 TABLET, FILM COATED in 1 BOTTLE (16714-637-02) 2017-06-020000-00-00NoNoCurrent
16714-637-03167140637031000 TABLET, FILM COATED in 1 BOTTLE (16714-637-03) 2017-06-150000-00-00NoNoCurrent