Home NDC 0228-2672 Spironolactone
Product NDC 0228-2672
11-digit product format 002282672
Labeler code 0228
Product ID 0228-2672_c2c9d105-84e7-4a04-807f-d236959c0742
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Spironolactone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA040353
Marketing category ANDA
Marketing start 2007-01-03
Marketing end 2020-09-30
Substance SPIRONOLACTONE
Active strength 50 mg/1
Pharmacologic classes Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040353-001 SPIRONOLACTONE SPIRONOLACTONE 50MG TABLET / ORAL 1999-07-29 A040353-002 SPIRONOLACTONE SPIRONOLACTONE 100MG TABLET / ORAL 1999-07-29 A040353-003 SPIRONOLACTONE SPIRONOLACTONE 25MG TABLET / ORAL 2006-03-15
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 123 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A040353-001 SPIRONOLACTONE 50MG TABLET / ORAL 1999-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040353-002 SPIRONOLACTONE 100MG TABLET / ORAL 1999-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040353-003 SPIRONOLACTONE 25MG TABLET / ORAL 2006-03-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040353-001 SPIRONOLACTONE 50MG TABLET / ORAL 1999-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040353-002 SPIRONOLACTONE 100MG TABLET / ORAL 1999-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040353-003 SPIRONOLACTONE 25MG TABLET / ORAL 2006-03-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040353-001 SPIRONOLACTONE 50MG TABLET / ORAL 1999-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040353-002 SPIRONOLACTONE 100MG TABLET / ORAL 1999-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040353-003 SPIRONOLACTONE 25MG TABLET / ORAL 2006-03-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040353-001 SPIRONOLACTONE 50MG TABLET / ORAL 1999-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040353-002 SPIRONOLACTONE 100MG TABLET / ORAL 1999-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040353-003 SPIRONOLACTONE 25MG TABLET / ORAL 2006-03-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040353-001 SPIRONOLACTONE 50MG TABLET / ORAL 1999-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040353-002 SPIRONOLACTONE 100MG TABLET / ORAL 1999-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040353-003 SPIRONOLACTONE 25MG TABLET / ORAL 2006-03-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040353-001 SPIRONOLACTONE 50MG TABLET / ORAL 1999-07-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040353-002 SPIRONOLACTONE 100MG TABLET / ORAL 1999-07-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040353-003 SPIRONOLACTONE 25MG TABLET / ORAL 2006-03-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040353-001 SPIRONOLACTONE 50MG TABLET / ORAL 1999-07-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040353-002 SPIRONOLACTONE 100MG TABLET / ORAL 1999-07-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040353-003 SPIRONOLACTONE 25MG TABLET / ORAL 2006-03-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040353-001 SPIRONOLACTONE 50MG TABLET / ORAL 1999-07-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040353-002 SPIRONOLACTONE 100MG TABLET / ORAL 1999-07-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040353-003 SPIRONOLACTONE 25MG TABLET / ORAL 2006-03-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040353-001 SPIRONOLACTONE 50MG TABLET / ORAL 1999-07-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040353-002 SPIRONOLACTONE 100MG TABLET / ORAL 1999-07-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040353-003 SPIRONOLACTONE 25MG TABLET / ORAL 2006-03-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040353-001 SPIRONOLACTONE 50MG TABLET / ORAL 1999-07-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040353-002 SPIRONOLACTONE 100MG TABLET / ORAL 1999-07-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040353-003 SPIRONOLACTONE 25MG TABLET / ORAL 2006-03-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040353-001 SPIRONOLACTONE 50MG TABLET / ORAL 1999-07-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040353-002 SPIRONOLACTONE 100MG TABLET / ORAL 1999-07-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040353-003 SPIRONOLACTONE 25MG TABLET / ORAL 2006-03-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040353-001 SPIRONOLACTONE 50MG TABLET / ORAL 1999-07-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040353-002 SPIRONOLACTONE 100MG TABLET / ORAL 1999-07-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040353-003 SPIRONOLACTONE 25MG TABLET / ORAL 2006-03-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040353-001 SPIRONOLACTONE 50MG TABLET / ORAL 1999-07-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040353-002 SPIRONOLACTONE 100MG TABLET / ORAL 1999-07-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040353-003 SPIRONOLACTONE 25MG TABLET / ORAL 2006-03-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040353-001 SPIRONOLACTONE 50MG TABLET / ORAL 1999-07-29 8072bd15b7f6…
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SPIRONOLACTONE ACTIVE INGREDIENT 27O7W4T232 SPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 8 SPIRONOLACTONE ACTIVE MOIETY 27O7W4T232 SPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 8 CALCIUM SULFATE INACTIVE INGREDIENT WAT0DDB505 SPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 8 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK SPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 8 DEXTROSE INACTIVE INGREDIENT IY9XDZ35W2 SPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 8 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 8 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D SPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 8 PEPPERMINT INACTIVE INGREDIENT V95R5KMY2B SPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 8 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE SPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 8 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 8 POVIDONE K29/32 INACTIVE INGREDIENT 390RMW2PEQ SPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 8 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 8 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 8 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 SPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 8 SPIRONOLACTONE ACTIVE INGREDIENT 27O7W4T232 SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 SPIRONOLACTONE ACTIVE MOIETY 27O7W4T232 SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 CALCIUM SULFATE INACTIVE INGREDIENT WAT0DDB505 SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 DEXTROSE INACTIVE INGREDIENT IY9XDZ35W2 SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 PEPPERMINT INACTIVE INGREDIENT V95R5KMY2B SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 POVIDONE INACTIVE INGREDIENT FZ989GH94E SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3
DailyMed RxNorm Mappings#