Home NDC 46708-115-01 Metoprolol Tartrate and Hydrochlorothiazide
Product NDC 46708-115
Requested package NDC 46708-115-01
11-digit product format 467080115
Labeler code 46708
Product ID 46708-115_5afb35ed-f222-47c7-ac02-3b1d062b09d2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metoprolol Tartrate and Hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA202870
Marketing category ANDA
Marketing start 2013-09-17
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A202870-001 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25MG;50MG TABLET / ORAL AB 2013-11-06 A202870-002 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25MG;100MG TABLET / ORAL AB 2013-11-06 A202870-003 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 50MG;100MG TABLET / ORAL AB 2013-11-06
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.
Product history page 1 of 4 · 132 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 2026-10-15 13:18:30 2026-09 A202870-001 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;50MG TABLET / ORAL AB 2013-11-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202870-002 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2013-11-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202870-003 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 50MG;100MG TABLET / ORAL AB 2013-11-06 c2088c7a36db…2026-09-14 22:38:34 2026-08 A202870-001 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;50MG TABLET / ORAL AB 2013-11-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202870-002 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2013-11-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202870-003 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 50MG;100MG TABLET / ORAL AB 2013-11-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202870-001 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;50MG TABLET / ORAL AB 2013-11-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202870-002 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2013-11-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202870-003 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 50MG;100MG TABLET / ORAL AB 2013-11-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202870-001 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;50MG TABLET / ORAL AB 2013-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202870-002 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB RS 2013-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202870-003 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 50MG;100MG TABLET / ORAL AB 2013-11-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202870-001 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;50MG TABLET / ORAL AB 2013-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202870-002 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB RS 2013-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202870-003 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 50MG;100MG TABLET / ORAL AB 2013-11-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202870-001 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;50MG TABLET / ORAL AB 2013-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202870-002 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB RS 2013-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202870-003 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 50MG;100MG TABLET / ORAL AB 2013-11-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202870-001 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;50MG TABLET / ORAL AB 2013-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202870-002 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB RS 2013-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202870-003 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 50MG;100MG TABLET / ORAL AB 2013-11-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202870-001 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;50MG TABLET / ORAL AB 2013-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202870-002 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB RS 2013-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202870-003 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 50MG;100MG TABLET / ORAL AB 2013-11-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202870-001 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;50MG TABLET / ORAL AB 2013-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202870-002 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB RS 2013-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202870-003 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 50MG;100MG TABLET / ORAL AB 2013-11-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202870-001 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;50MG TABLET / ORAL AB 2013-11-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202870-002 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB RS 2013-11-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202870-003 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 50MG;100MG TABLET / ORAL AB 2013-11-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202870-001 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;50MG TABLET / ORAL AB 2013-11-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202870-002 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB RS 2013-11-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202870-003 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 50MG;100MG TABLET / ORAL AB 2013-11-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202870-001 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;50MG TABLET / ORAL AB 2013-11-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202870-002 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB RS 2013-11-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202870-003 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 50MG;100MG TABLET / ORAL AB 2013-11-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202870-001 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;50MG TABLET / ORAL AB 2013-11-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202870-002 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB RS 2013-11-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202870-003 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 50MG;100MG TABLET / ORAL AB 2013-11-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202870-001 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 25MG;50MG TABLET / ORAL AB 2013-11-06 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
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 2027-12-31 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 866479 Internal RxNorm lookup 866482 Internal RxNorm lookup 866491 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 46708-115-01 Metoprolol Tartrate and Hydrochlorothiazide 1000 in 1 BOTTLE TABLET 1000 3 46708-115-10 Metoprolol Tartrate and Hydrochlorothiazide 100 in 1 BOTTLE TABLET 100 3 46708-115-30 Metoprolol Tartrate and Hydrochlorothiazide 30 in 1 BOTTLE TABLET 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-115 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [ALEMBIC PHARMACEUTICALS LIMITED] 3 Current NDC, Legacy NDC, 3 package rows 20230119_538ea34a-1ac3-48c8-b841-43be09285e12.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 46708-115-01 46708011501 1000 TABLET in 1 BOTTLE (46708-115-01) 1000 tablet 2013-09-17 0000-00-00 No No Current