Home NDC 72888-054-01 METOLAZONE
Product NDC 72888-054
Requested package NDC 72888-054-01
11-digit product format 728880054
Labeler code 72888
Product ID 72888-054_486ae202-9be8-35ef-e063-6294a90adb8a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name METOLAZONE
Dosage form TABLET
Route ORAL
Labeler Advagen Pharma Limited
Application ANDA215184
Marketing category ANDA
Marketing start 2021-08-20
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 A215184-001 METOLAZONE METOLAZONE 2.5MG TABLET / ORAL AB 2021-08-20 A215184-002 METOLAZONE METOLAZONE 5MG TABLET / ORAL AB 2021-08-20 A215184-003 METOLAZONE METOLAZONE 10MG TABLET / ORAL AB 2021-08-20
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 · 99 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 A215184-001 METOLAZONE 2.5MG TABLET / ORAL AB 2021-08-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215184-002 METOLAZONE 5MG TABLET / ORAL AB 2021-08-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215184-003 METOLAZONE 10MG TABLET / ORAL AB 2021-08-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215184-001 METOLAZONE 2.5MG TABLET / ORAL AB 2021-08-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215184-002 METOLAZONE 5MG TABLET / ORAL AB 2021-08-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215184-003 METOLAZONE 10MG TABLET / ORAL AB 2021-08-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215184-001 METOLAZONE 2.5MG TABLET / ORAL AB 2021-08-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215184-002 METOLAZONE 5MG TABLET / ORAL AB 2021-08-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215184-003 METOLAZONE 10MG TABLET / ORAL AB 2021-08-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215184-001 METOLAZONE 2.5MG TABLET / ORAL AB 2021-08-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215184-002 METOLAZONE 5MG TABLET / ORAL AB 2021-08-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215184-003 METOLAZONE 10MG TABLET / ORAL AB 2021-08-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215184-001 METOLAZONE 2.5MG TABLET / ORAL AB 2021-08-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215184-002 METOLAZONE 5MG TABLET / ORAL AB 2021-08-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215184-003 METOLAZONE 10MG TABLET / ORAL AB 2021-08-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215184-001 METOLAZONE 2.5MG TABLET / ORAL AB 2021-08-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215184-002 METOLAZONE 5MG TABLET / ORAL AB 2021-08-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215184-003 METOLAZONE 10MG TABLET / ORAL AB 2021-08-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215184-001 METOLAZONE 2.5MG TABLET / ORAL AB 2021-08-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215184-002 METOLAZONE 5MG TABLET / ORAL AB 2021-08-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215184-003 METOLAZONE 10MG TABLET / ORAL AB 2021-08-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215184-001 METOLAZONE 2.5MG TABLET / ORAL AB 2021-08-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215184-002 METOLAZONE 5MG TABLET / ORAL AB 2021-08-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215184-003 METOLAZONE 10MG TABLET / ORAL AB 2021-08-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215184-001 METOLAZONE 2.5MG TABLET / ORAL AB 2021-08-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215184-002 METOLAZONE 5MG TABLET / ORAL AB 2021-08-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215184-003 METOLAZONE 10MG TABLET / ORAL AB 2021-08-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215184-001 METOLAZONE 2.5MG TABLET / ORAL AB 2021-08-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215184-002 METOLAZONE 5MG TABLET / ORAL AB 2021-08-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215184-003 METOLAZONE 10MG TABLET / ORAL AB 2021-08-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215184-001 METOLAZONE 2.5MG TABLET / ORAL AB 2021-08-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215184-002 METOLAZONE 5MG TABLET / ORAL AB 2021-08-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215184-003 METOLAZONE 10MG TABLET / ORAL AB 2021-08-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215184-001 METOLAZONE 2.5MG TABLET / ORAL AB 2021-08-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215184-002 METOLAZONE 5MG TABLET / ORAL AB 2021-08-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215184-003 METOLAZONE 10MG TABLET / ORAL AB 2021-08-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215184-001 METOLAZONE 2.5MG TABLET / ORAL AB 2021-08-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215184-002 METOLAZONE 5MG TABLET / ORAL AB 2021-08-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215184-003 METOLAZONE 10MG TABLET / ORAL AB 2021-08-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215184-001 METOLAZONE 2.5MG TABLET / ORAL AB 2021-08-20 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 99 observed states.
Additional Listing Data#
Finished product Yes
Brand name base METOLAZONE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METOLAZONE 10 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 72888-054-01 METOLAZONE 100 in 1 BOTTLE TABLET 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72888-054 METOLAZONE TABLET [ADVAGEN PHARMA LIMITED] 2 Current NDC, Legacy NDC, 1 package rows 20221018_6a9c8415-e389-7a9a-73de-532cf3f57ac5.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 · 2 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 72888-054-01 72888005401 100 TABLET in 1 BOTTLE (72888-054-01) 100 tablet 2021-08-20 0000-00-00 No No Current