Home NDC 0185-5050 Metolazone
Product NDC 0185-5050
11-digit product format 001855050
Labeler code 0185
Product ID 0185-5050_5d900b8f-93d6-46d0-8db9-7fe9e3791a2f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metolazone
Dosage form TABLET
Route ORAL
Labeler Sandoz Inc
Application ANDA076732
Marketing category ANDA
Marketing start 2003-12-19
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076732-001 METOLAZONE METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076732-001 AB
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 · 41 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 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076732-001 METOLAZONE 2.5MG TABLET / ORAL AB 2003-12-19 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 0185-5050-01 Metolazone 100 in 1 BOTTLE TABLET 100 20 0185-5050-10 Metolazone 1000 in 1 BOTTLE TABLET 1000 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METOLAZONE ACTIVE INGREDIENT TZ7V40X7VX METOLAZONE TABLET [EON LABS, INC.] 16 METOLAZONE ACTIVE MOIETY TZ7V40X7VX METOLAZONE TABLET [EON LABS, INC.] 16 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METOLAZONE TABLET [EON LABS, INC.] 16 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B METOLAZONE TABLET [EON LABS, INC.] 16 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G METOLAZONE TABLET [EON LABS, INC.] 16 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK METOLAZONE TABLET [EON LABS, INC.] 16 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 METOLAZONE TABLET [EON LABS, INC.] 16 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METOLAZONE TABLET [EON LABS, INC.] 16 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METOLAZONE TABLET [EON LABS, INC.] 16 METOLAZONE ACTIVE INGREDIENT TZ7V40X7VX METOLAZONE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 METOLAZONE ACTIVE MOIETY TZ7V40X7VX METOLAZONE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METOLAZONE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B METOLAZONE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK METOLAZONE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METOLAZONE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METOLAZONE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 METOLAZONE ACTIVE INGREDIENT TZ7V40X7VX METOLAZONE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 METOLAZONE ACTIVE MOIETY TZ7V40X7VX METOLAZONE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METOLAZONE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B METOLAZONE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G METOLAZONE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK METOLAZONE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 METOLAZONE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METOLAZONE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METOLAZONE TABLET [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0185-5050 METOLAZONE TABLET [SANDOZ INC] 19 Current NDC, Legacy NDC, 2 package rows 20240316_0b619826-2567-49d7-8972-b6da5e4467df.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 0185-5050-01 00185505001 100 TABLET in 1 BOTTLE (0185-5050-01) 100 tablet 2003-12-19 0000-00-00 No No Current 0185-5050-10 00185505010 1000 TABLET in 1 BOTTLE (0185-5050-10) 1000 tablet 2003-12-19 0000-00-00 No No Current