Home NDC 27241-301 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
Product NDC 27241-301
11-digit product format 272410301
Labeler code 27241
Product ID 27241-301_c1d86752-98ac-48af-8023-e57b40270660
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name metoprolol tartrate and hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler Ajanta Pharma USA Inc.
Application ANDA215789
Marketing category ANDA
Marketing start 2025-03-15
Substance METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE
Active strength 50; 25 mg/1; mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [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 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215789-001 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25MG;50MG TABLET / ORAL AB 2025-01-08 A215789-002 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25MG;100MG TABLET / ORAL AB 2025-01-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2026-09-14 22:38:34 2026-08 A215789-001 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;50MG TABLET / ORAL AB 2025-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215789-002 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2025-01-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215789-001 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;50MG TABLET / ORAL AB 2025-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215789-002 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2025-01-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215789-001 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;50MG TABLET / ORAL AB 2025-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215789-002 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2025-01-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215789-001 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;50MG TABLET / ORAL AB 2025-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215789-002 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2025-01-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215789-001 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;50MG TABLET / ORAL AB 2025-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215789-002 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2025-01-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215789-001 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;50MG TABLET / ORAL AB 2025-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215789-002 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2025-01-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215789-001 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;50MG TABLET / ORAL AB 2025-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215789-002 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2025-01-08 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215789-001 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;50MG TABLET / ORAL AB 2025-01-08 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215789-002 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2025-01-08 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METOPROLOL TARTRATE 50 mg/1 HYDROCHLOROTHIAZIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W5S57Y3A5L Internal UNII lookup 0J48LPH2TH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 866479 Internal RxNorm lookup 866482 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 27241-301-01 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 100 in 1 BOTTLE TABLET 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 27241-301 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [AJANTA PHARMA USA INC.] 1 Current NDC, 1 package rows 20250410_8b78d7ad-22a8-4a9f-afb5-d18f0a4e6d36.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 · 1 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 27241-301-01 27241030101 100 TABLET in 1 BOTTLE (27241-301-01) 100 tablet 2025-03-15 No No Current