Home NDC 42571-418 Metolazone
Product NDC 42571-418
11-digit product format 425710418
Labeler code 42571
Product ID 42571-418_47da5a45-3e85-bb97-e063-6294a90a545c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metolazone
Dosage form TABLET
Route ORAL
Labeler Micro Labs Limited
Application ANDA217563
Marketing category ANDA
Marketing start 2025-03-01
Substance METOLAZONE
Active strength 10 mg/1
Pharmacologic classes Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 A217563-001 METOLAZONE METOLAZONE 2.5MG TABLET / ORAL AB 2024-11-06 A217563-002 METOLAZONE METOLAZONE 5MG TABLET / ORAL AB 2024-11-06 A217563-003 METOLAZONE METOLAZONE 10MG TABLET / ORAL AB 2024-11-06
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.
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 A217563-001 METOLAZONE 2.5MG TABLET / ORAL AB 2024-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217563-002 METOLAZONE 5MG TABLET / ORAL AB 2024-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217563-003 METOLAZONE 10MG TABLET / ORAL AB 2024-11-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217563-001 METOLAZONE 2.5MG TABLET / ORAL AB 2024-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217563-002 METOLAZONE 5MG TABLET / ORAL AB 2024-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217563-003 METOLAZONE 10MG TABLET / ORAL AB 2024-11-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217563-001 METOLAZONE 2.5MG TABLET / ORAL AB 2024-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217563-002 METOLAZONE 5MG TABLET / ORAL AB 2024-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217563-003 METOLAZONE 10MG TABLET / ORAL AB 2024-11-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217563-001 METOLAZONE 2.5MG TABLET / ORAL AB 2024-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217563-002 METOLAZONE 5MG TABLET / ORAL AB 2024-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217563-003 METOLAZONE 10MG TABLET / ORAL AB 2024-11-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217563-001 METOLAZONE 2.5MG TABLET / ORAL AB 2024-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217563-002 METOLAZONE 5MG TABLET / ORAL AB 2024-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217563-003 METOLAZONE 10MG TABLET / ORAL AB 2024-11-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217563-001 METOLAZONE 2.5MG TABLET / ORAL AB 2024-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217563-002 METOLAZONE 5MG TABLET / ORAL AB 2024-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217563-003 METOLAZONE 10MG TABLET / ORAL AB 2024-11-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217563-001 METOLAZONE 2.5MG TABLET / ORAL AB 2024-11-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217563-002 METOLAZONE 5MG TABLET / ORAL AB 2024-11-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217563-003 METOLAZONE 10MG TABLET / ORAL AB 2024-11-06 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217563-001 METOLAZONE 2.5MG TABLET / ORAL AB 2024-11-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217563-002 METOLAZONE 5MG TABLET / ORAL AB 2024-11-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217563-003 METOLAZONE 10MG TABLET / ORAL AB 2024-11-06 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217563-001 METOLAZONE 2.5MG TABLET / ORAL AB 2024-11-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217563-002 METOLAZONE 5MG TABLET / ORAL AB 2024-11-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217563-003 METOLAZONE 10MG TABLET / ORAL AB 2024-11-06 a50c72e98297…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42571-418-01 Metolazone 100 in 1 CONTAINER TABLET 100 2 42571-418-10 Metolazone 1000 in 1 CONTAINER TABLET 1000 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42571-418 METOLAZONE (METOLAZONE) TABLET [MICRO LABS LIMITED] 1 Current NDC, 2 package rows 20250302_9ab471a1-0f71-4452-ba57-518dcc6f9f18.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42571-418-01 42571041801 100 TABLET in 1 CONTAINER (42571-418-01) 100 tablet 2025-03-01 No No Historical 42571-418-10 42571041810 1000 TABLET in 1 CONTAINER (42571-418-10) 1000 tablet 2025-03-01 No No Historical