Home NDC 0904-7521 Metolazone
Product NDC 0904-7521
11-digit product format 009047521
Labeler code 0904
Product ID 0904-7521_89201e19-d0e8-4192-b2a1-150e9d2c104d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metolazone
Dosage form TABLET
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA215616
Marketing category ANDA
Marketing start 2025-11-20
Substance METOLAZONE
Active strength 5 mg/1
Pharmacologic classes Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 A215616-001 METOLAZONE METOLAZONE 2.5MG TABLET / ORAL AB 2022-10-24 A215616-002 METOLAZONE METOLAZONE 5MG TABLET / ORAL AB 2022-10-24 A215616-003 METOLAZONE METOLAZONE 10MG TABLET / ORAL AB 2022-10-24
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 2 · 75 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 A215616-001 METOLAZONE 2.5MG TABLET / ORAL AB 2022-10-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215616-002 METOLAZONE 5MG TABLET / ORAL AB 2022-10-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215616-003 METOLAZONE 10MG TABLET / ORAL AB 2022-10-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215616-001 METOLAZONE 2.5MG TABLET / ORAL AB 2022-10-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215616-002 METOLAZONE 5MG TABLET / ORAL AB 2022-10-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215616-003 METOLAZONE 10MG TABLET / ORAL AB 2022-10-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215616-001 METOLAZONE 2.5MG TABLET / ORAL AB 2022-10-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215616-002 METOLAZONE 5MG TABLET / ORAL AB 2022-10-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215616-003 METOLAZONE 10MG TABLET / ORAL AB 2022-10-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215616-001 METOLAZONE 2.5MG TABLET / ORAL AB 2022-10-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215616-002 METOLAZONE 5MG TABLET / ORAL AB 2022-10-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215616-003 METOLAZONE 10MG TABLET / ORAL AB 2022-10-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215616-001 METOLAZONE 2.5MG TABLET / ORAL AB 2022-10-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215616-002 METOLAZONE 5MG TABLET / ORAL AB 2022-10-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215616-003 METOLAZONE 10MG TABLET / ORAL AB 2022-10-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215616-001 METOLAZONE 2.5MG TABLET / ORAL AB 2022-10-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215616-002 METOLAZONE 5MG TABLET / ORAL AB 2022-10-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215616-003 METOLAZONE 10MG TABLET / ORAL AB 2022-10-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215616-001 METOLAZONE 2.5MG TABLET / ORAL AB 2022-10-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215616-002 METOLAZONE 5MG TABLET / ORAL AB 2022-10-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215616-003 METOLAZONE 10MG TABLET / ORAL AB 2022-10-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215616-001 METOLAZONE 2.5MG TABLET / ORAL AB 2022-10-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215616-002 METOLAZONE 5MG TABLET / ORAL AB 2022-10-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215616-003 METOLAZONE 10MG TABLET / ORAL AB 2022-10-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215616-001 METOLAZONE 2.5MG TABLET / ORAL AB 2022-10-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215616-002 METOLAZONE 5MG TABLET / ORAL AB 2022-10-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215616-003 METOLAZONE 10MG TABLET / ORAL AB 2022-10-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215616-001 METOLAZONE 2.5MG TABLET / ORAL AB 2022-10-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215616-002 METOLAZONE 5MG TABLET / ORAL AB 2022-10-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215616-003 METOLAZONE 10MG TABLET / ORAL AB 2022-10-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215616-001 METOLAZONE 2.5MG TABLET / ORAL AB 2022-10-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215616-002 METOLAZONE 5MG TABLET / ORAL AB 2022-10-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215616-003 METOLAZONE 10MG TABLET / ORAL AB 2022-10-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215616-001 METOLAZONE 2.5MG TABLET / ORAL AB 2022-10-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215616-002 METOLAZONE 5MG TABLET / ORAL AB 2022-10-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215616-003 METOLAZONE 10MG TABLET / ORAL AB 2022-10-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215616-001 METOLAZONE 2.5MG TABLET / ORAL AB 2022-10-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215616-002 METOLAZONE 5MG TABLET / ORAL AB 2022-10-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215616-003 METOLAZONE 10MG TABLET / ORAL AB 2022-10-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215616-001 METOLAZONE 2.5MG TABLET / ORAL AB 2022-10-24 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 75 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Metolazone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METOLAZONE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TZ7V40X7VX Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197979 Internal RxNorm lookup 311671 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0904-7521-61 Metolazone 1 in 1 BLISTER PACK TABLET 1 1 0904-7521-61 Metolazone 100 in 1 CARTON TABLET 100 1
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0904-7521-61 00904752161 100 BLISTER PACK in 1 CARTON (0904-7521-61) / 1 TABLET in 1 BLISTER PACK 100 blister pack 2025-11-20 No No Current