Home NDC 49999-811 Spironolactone
Product NDC 49999-811
11-digit product format 499990811
Labeler code 49999
Product ID 49999-811_f8463b5d-350c-4c4b-b05d-95ec3b168fa0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Spironolactone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Lake Erie Medical DBA Quality Care Products LLC
Application ANDA040353
Marketing category ANDA
Marketing start 2007-01-03
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 2019-12-31
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 · 48 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…