Home NDC 0378-6172 Metolazone
Product NDC 0378-6172
11-digit product format 003786172
Labeler code 0378
Product ID 0378-6172_80dfdc38-4f24-4670-9341-bee52a95fd49
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name metolazone
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA076698
Marketing category ANDA
Marketing start 2004-01-06
Substance METOLAZONE
Active strength 2.5 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 A076698-001 METOLAZONE METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-23 A076698-002 METOLAZONE METOLAZONE 5MG TABLET / ORAL AB 2004-10-19 A076698-003 METOLAZONE METOLAZONE 10MG TABLET / ORAL AB 2004-10-19
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 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 A076698-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076698-002 METOLAZONE 5MG TABLET / ORAL AB 2004-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076698-003 METOLAZONE 10MG TABLET / ORAL AB 2004-10-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076698-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076698-002 METOLAZONE 5MG TABLET / ORAL AB 2004-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076698-003 METOLAZONE 10MG TABLET / ORAL AB 2004-10-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076698-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076698-002 METOLAZONE 5MG TABLET / ORAL AB 2004-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076698-003 METOLAZONE 10MG TABLET / ORAL AB 2004-10-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076698-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076698-002 METOLAZONE 5MG TABLET / ORAL AB 2004-10-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076698-003 METOLAZONE 10MG TABLET / ORAL AB 2004-10-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076698-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076698-002 METOLAZONE 5MG TABLET / ORAL AB 2004-10-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076698-003 METOLAZONE 10MG TABLET / ORAL AB 2004-10-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076698-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076698-002 METOLAZONE 5MG TABLET / ORAL AB 2004-10-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076698-003 METOLAZONE 10MG TABLET / ORAL AB 2004-10-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076698-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076698-002 METOLAZONE 5MG TABLET / ORAL AB 2004-10-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076698-003 METOLAZONE 10MG TABLET / ORAL AB 2004-10-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076698-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076698-002 METOLAZONE 5MG TABLET / ORAL AB 2004-10-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076698-003 METOLAZONE 10MG TABLET / ORAL AB 2004-10-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076698-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076698-002 METOLAZONE 5MG TABLET / ORAL AB 2004-10-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076698-003 METOLAZONE 10MG TABLET / ORAL AB 2004-10-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076698-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076698-002 METOLAZONE 5MG TABLET / ORAL AB 2004-10-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076698-003 METOLAZONE 10MG TABLET / ORAL AB 2004-10-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076698-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076698-002 METOLAZONE 5MG TABLET / ORAL AB 2004-10-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076698-003 METOLAZONE 10MG TABLET / ORAL AB 2004-10-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076698-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076698-002 METOLAZONE 5MG TABLET / ORAL AB 2004-10-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076698-003 METOLAZONE 10MG TABLET / ORAL AB 2004-10-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076698-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076698-002 METOLAZONE 5MG TABLET / ORAL AB 2004-10-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076698-003 METOLAZONE 10MG TABLET / ORAL AB 2004-10-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076698-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-23 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 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 2.5 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197978 Internal RxNorm lookup 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 0378-6172-01 Metolazone 100 in 1 BOTTLE, PLASTIC TABLET 100 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METOLAZONE ACTIVE INGREDIENT TZ7V40X7VX METOLAZONE TABLET [MYLAN PHARMACEUTICALS INC.] 4 METOLAZONE ACTIVE MOIETY TZ7V40X7VX METOLAZONE TABLET [MYLAN PHARMACEUTICALS INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METOLAZONE TABLET [MYLAN PHARMACEUTICALS INC.] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G METOLAZONE TABLET [MYLAN PHARMACEUTICALS INC.] 4 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK METOLAZONE TABLET [MYLAN PHARMACEUTICALS INC.] 4 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 METOLAZONE TABLET [MYLAN PHARMACEUTICALS INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METOLAZONE TABLET [MYLAN PHARMACEUTICALS INC.] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METOLAZONE TABLET [MYLAN PHARMACEUTICALS INC.] 4 METOLAZONE ACTIVE INGREDIENT TZ7V40X7VX METOLAZONE TABLET [MYLAN INSTITUTIONAL INC.] 2 METOLAZONE ACTIVE INGREDIENT TZ7V40X7VX METOLAZONE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 METOLAZONE ACTIVE MOIETY TZ7V40X7VX METOLAZONE TABLET [MYLAN INSTITUTIONAL INC.] 2 METOLAZONE ACTIVE MOIETY TZ7V40X7VX METOLAZONE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METOLAZONE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METOLAZONE TABLET [MYLAN INSTITUTIONAL INC.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 METOLAZONE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 METOLAZONE TABLET [MYLAN INSTITUTIONAL INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METOLAZONE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METOLAZONE TABLET [MYLAN INSTITUTIONAL INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METOLAZONE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METOLAZONE TABLET [MYLAN INSTITUTIONAL INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-6172 METOLAZONE TABLET [MYLAN PHARMACEUTICALS INC.] 13 Current NDC, Legacy NDC, 1 package rows 20241206_6639d111-eb21-4997-b964-f5c61bc088f2.zip
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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0378-6172-01 00378617201 100 TABLET in 1 BOTTLE, PLASTIC (0378-6172-01) 100 tablet 2004-01-06 0000-00-00 No No Current