Home NDC 0904-7138-61 METOLAZONE
Product NDC 0904-7138
Requested package NDC 0904-7138-61
11-digit product format 009047138
Labeler code 0904
Product ID 0904-7138_822bb0ac-1b6c-4132-afca-d0d0633d1843
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name METOLAZONE
Dosage form TABLET
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA213251
Marketing category ANDA
Marketing start 2020-12-02
Marketing end 0000-00-00
Substance METOLAZONE
Active strength 3 mg/1
Pharmacologic classes Increased Diuresis [PE],Thiazide-like Diuretic [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A213251-001 METOLAZONE METOLAZONE 2.5MG TABLET / ORAL AB 2020-12-02 A213251-002 METOLAZONE METOLAZONE 5MG TABLET / ORAL AB 2020-12-02 A213251-003 METOLAZONE METOLAZONE 10MG TABLET / ORAL AB 2020-12-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 3 · 108 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 A213251-001 METOLAZONE 2.5MG TABLET / ORAL AB 2020-12-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213251-002 METOLAZONE 5MG TABLET / ORAL AB 2020-12-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213251-003 METOLAZONE 10MG TABLET / ORAL AB 2020-12-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213251-001 METOLAZONE 2.5MG TABLET / ORAL AB 2020-12-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213251-002 METOLAZONE 5MG TABLET / ORAL AB 2020-12-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213251-003 METOLAZONE 10MG TABLET / ORAL AB 2020-12-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213251-001 METOLAZONE 2.5MG TABLET / ORAL AB 2020-12-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213251-002 METOLAZONE 5MG TABLET / ORAL AB 2020-12-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213251-003 METOLAZONE 10MG TABLET / ORAL AB 2020-12-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213251-001 METOLAZONE 2.5MG TABLET / ORAL AB 2020-12-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213251-002 METOLAZONE 5MG TABLET / ORAL AB 2020-12-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213251-003 METOLAZONE 10MG TABLET / ORAL AB 2020-12-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213251-001 METOLAZONE 2.5MG TABLET / ORAL AB 2020-12-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213251-002 METOLAZONE 5MG TABLET / ORAL AB 2020-12-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213251-003 METOLAZONE 10MG TABLET / ORAL AB 2020-12-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213251-001 METOLAZONE 2.5MG TABLET / ORAL AB 2020-12-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213251-002 METOLAZONE 5MG TABLET / ORAL AB 2020-12-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213251-003 METOLAZONE 10MG TABLET / ORAL AB 2020-12-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213251-001 METOLAZONE 2.5MG TABLET / ORAL AB 2020-12-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213251-002 METOLAZONE 5MG TABLET / ORAL AB 2020-12-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213251-003 METOLAZONE 10MG TABLET / ORAL AB 2020-12-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213251-001 METOLAZONE 2.5MG TABLET / ORAL AB 2020-12-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213251-002 METOLAZONE 5MG TABLET / ORAL AB 2020-12-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213251-003 METOLAZONE 10MG TABLET / ORAL AB 2020-12-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213251-001 METOLAZONE 2.5MG TABLET / ORAL AB 2020-12-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213251-002 METOLAZONE 5MG TABLET / ORAL AB 2020-12-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213251-003 METOLAZONE 10MG TABLET / ORAL AB 2020-12-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213251-001 METOLAZONE 2.5MG TABLET / ORAL AB 2020-12-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213251-002 METOLAZONE 5MG TABLET / ORAL AB 2020-12-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213251-003 METOLAZONE 10MG TABLET / ORAL AB 2020-12-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213251-001 METOLAZONE 2.5MG TABLET / ORAL AB 2020-12-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213251-002 METOLAZONE 5MG TABLET / ORAL AB 2020-12-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213251-003 METOLAZONE 10MG TABLET / ORAL AB 2020-12-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213251-001 METOLAZONE 2.5MG TABLET / ORAL AB 2020-12-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213251-002 METOLAZONE 5MG TABLET / ORAL AB 2020-12-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213251-003 METOLAZONE 10MG TABLET / ORAL AB 2020-12-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213251-001 METOLAZONE 2.5MG TABLET / ORAL AB 2020-12-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213251-002 METOLAZONE 5MG TABLET / ORAL AB 2020-12-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213251-003 METOLAZONE 10MG TABLET / ORAL AB 2020-12-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213251-001 METOLAZONE 2.5MG TABLET / ORAL AB 2020-12-02 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 108 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0904-7138-61 00904713861 100 BLISTER PACK in 1 CARTON (0904-7138-61) > 1 TABLET in 1 BLISTER PACK 100 blister pack 2020-12-02 0000-00-00 No No Current