FDA.reportPublic FDA data

Metoprolol Tartrate and Hydrochlorothiazide

Product NDC
46708-116
11-digit product format
467080116
Labeler code
46708
Product ID
46708-116_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
HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE
Active strength
25; 100 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE25MG;50MGTABLET / ORALAB2013-11-06
A202870-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE25MG;100MGTABLET / ORALAB2013-11-06
A202870-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE50MG;100MGTABLET / ORALAB2013-11-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A202870-001AB
A202870-002AB
A202870-003AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2013-11-0684e616aacf4f…
2026-09-14 22:38:342026-08A202870-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2013-11-0684e616aacf4f…
2026-09-14 22:38:342026-08A202870-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2013-11-0684e616aacf4f…
2026-08-18 06:07:402026-07A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2013-11-06caaa826d4ba7…
2026-08-18 06:07:402026-07A202870-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2013-11-06caaa826d4ba7…
2026-08-18 06:07:402026-07A202870-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2013-11-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2013-11-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202870-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2013-11-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202870-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2013-11-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2013-11-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202870-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2013-11-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202870-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2013-11-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2013-11-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202870-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2013-11-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202870-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2013-11-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2013-11-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202870-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2013-11-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202870-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2013-11-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2013-11-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202870-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2013-11-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202870-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2013-11-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2013-11-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202870-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2013-11-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202870-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2013-11-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2013-11-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202870-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2013-11-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202870-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2013-11-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2013-11-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202870-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2013-11-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202870-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2013-11-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2013-11-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202870-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2013-11-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202870-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2013-11-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2013-11-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A202870-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2013-11-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A202870-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2013-11-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2013-11-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202870-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2013-11-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202870-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2013-11-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2013-11-06301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A202870-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A202870-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A202870-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A202870-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202870-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202870-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202870-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202870-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202870-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202870-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202870-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202870-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202870-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202870-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202870-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202870-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202870-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202870-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202870-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202870-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202870-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202870-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202870-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202870-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202870-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202870-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202870-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202870-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202870-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202870-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202870-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202870-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202870-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202870-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202870-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202870-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202870-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202870-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202870-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202870-001AB1301d65b070ca…

Additional Listing Data#

Finished product
Yes
Brand name base
Metoprolol Tartrate and Hydrochlorothiazide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL TARTRATE100 mg/1
HYDROCHLOROTHIAZIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0J48LPH2THInternal UNII lookup
W5S57Y3A5LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
866479Internal RxNorm lookup
866482Internal RxNorm lookup
866491Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
538ea34a-1ac3-48c8-b841-43be09285e12Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
fac0d979-ed64-4395-be9a-fc0b6f8c0a4fProduct name120260122
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
07ea0487-5434-6896-2497-013a7ee4afbdProduct name920250311
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
95ced987-af5e-4bea-8119-4e7d4558d21bProduct name220200617
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
9ab5a42a-e77d-486b-bb1f-b343fe664adaProduct name120180430
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
310125de-e7c0-730d-d178-98b990a0334aProduct name220150324
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-116-10Metoprolol Tartrate and Hydrochlorothiazide100 in 1 BOTTLETABLET1003
46708-116-30Metoprolol Tartrate and Hydrochlorothiazide30 in 1 BOTTLETABLET303
46708-116-50Metoprolol Tartrate and Hydrochlorothiazide500 in 1 BOTTLETABLET5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-116METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]3Current NDC, Legacy NDC, 3 package rows20230119_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metoprolol Tartrate and HydrochlorothiazideMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Inc.2b77f66f-6891-4977-be8f-7955473d2f922024-01-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202870
application number: ANDA202870
Metoprolol Tartrate and HydrochlorothiazideMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limited538ea34a-1ac3-48c8-b841-43be09285e122023-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202870
application number: ANDA202870
ndc (product): 46708-116

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866479metoprolol tartrate 100 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN538ea34a-1ac3-48c8-b841-43be09285e123
866491metoprolol tartrate 100 MG / hydroCHLOROthiazide 50 MG Oral TabletPSN538ea34a-1ac3-48c8-b841-43be09285e123
866482metoprolol tartrate 50 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN538ea34a-1ac3-48c8-b841-43be09285e123
866479hydrochlorothiazide 25 MG / metoprolol tartrate 100 MG Oral TabletSCD538ea34a-1ac3-48c8-b841-43be09285e123
866482hydrochlorothiazide 25 MG / metoprolol tartrate 50 MG Oral TabletSCD538ea34a-1ac3-48c8-b841-43be09285e123
866491hydrochlorothiazide 50 MG / metoprolol tartrate 100 MG Oral TabletSCD538ea34a-1ac3-48c8-b841-43be09285e123
866479HCTZ 25 MG / metoprolol tartrate 100 MG Oral TabletSY538ea34a-1ac3-48c8-b841-43be09285e123
866482HCTZ 25 MG / metoprolol tartrate 50 MG Oral TabletSY538ea34a-1ac3-48c8-b841-43be09285e123
866491HCTZ 50 MG / metoprolol tartrate 100 MG Oral TabletSY538ea34a-1ac3-48c8-b841-43be09285e123

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-116-1046708011610100 TABLET in 1 BOTTLE (46708-116-10) 100 tablet2013-09-170000-00-00NoNoCurrent
46708-116-304670801163030 TABLET in 1 BOTTLE (46708-116-30) 30 tablet2013-09-170000-00-00NoNoCurrent
46708-116-5046708011650500 TABLET in 1 BOTTLE (46708-116-50) 500 tablet2013-09-170000-00-00NoNoCurrent