Home NDC 13107-062 Metoprolol Tartrate
Product NDC 13107-062
11-digit product format 131070062
Labeler code 13107
Product ID 13107-062_88f1abdc-f53e-4ff9-b4c1-3cfbc2609b79
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metoprolol Tartrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurolife Pharma LLC
Application ANDA077739
Marketing category ANDA
Marketing start 2010-09-17
Marketing end 0000-00-00
Substance METOPROLOL TARTRATE
Active strength 25 mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077739-001 METOPROLOL TARTRATE METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2007-09-11 A077739-002 METOPROLOL TARTRATE METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2007-09-11 A077739-003 METOPROLOL TARTRATE METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2007-09-11 A077739-004 METOPROLOL TARTRATE METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2023-12-07 A077739-005 METOPROLOL TARTRATE METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2023-12-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 5 · 167 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 2026-09-14 22:38:34 2026-08 A077739-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2007-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077739-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2007-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077739-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2007-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077739-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2023-12-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077739-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2023-12-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077739-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2007-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077739-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2007-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077739-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2007-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077739-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2023-12-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077739-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2023-12-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077739-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2007-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077739-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2007-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077739-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2007-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077739-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2023-12-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077739-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2023-12-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077739-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2007-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077739-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2007-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077739-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2007-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077739-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2023-12-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077739-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2023-12-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077739-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2007-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077739-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2007-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077739-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2007-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077739-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2023-12-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077739-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2023-12-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077739-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2007-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077739-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2007-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077739-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2007-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077739-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2023-12-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077739-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2023-12-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077739-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2007-09-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077739-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2007-09-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077739-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2007-09-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077739-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2023-12-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077739-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2023-12-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077739-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2007-09-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077739-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2007-09-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077739-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2007-09-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077739-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2023-12-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077739-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2023-12-07 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 167 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 13107-062-01 Metoprolol Tartrate 100 in 1 BOTTLE TABLET, FILM COATED 100 1 13107-062-99 Metoprolol Tartrate 1000 in 1 BOTTLE TABLET, FILM COATED 1000 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METOPROLOL TARTRATE ACTIVE INGREDIENT W5S57Y3A5L METOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC] 1 METOPROLOL ACTIVE MOIETY GEB06NHM23 METOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC] 1 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B METOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK METOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC] 1 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 METOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A METOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H METOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC] 1 SODIUM GLYCOLATE INACTIVE INGREDIENT B75E535IMI METOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J METOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U METOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP METOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13107-062 METOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC] 1 Legacy NDC, 2 package rows 20110620_88f1abdc-f53e-4ff9-b4c1-3cfbc2609b79.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 3 of 3 · 41 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 13107-062-01 13107006201 100 in 1 BOTTLE Historical 13107-062-99 13107006299 1000 in 1 BOTTLE Historical