Home NDC 57664-162 Metoprolol tartrate
Product NDC 57664-162
11-digit product format 576640162
Labeler code 57664
Product ID 57664-162_efa4b809-f526-5cd8-e053-2a95a90afeae
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metoprolol tartrate
Dosage form TABLET
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA074644
Marketing category ANDA
Marketing start 2015-06-29
Marketing end 0000-00-00
Substance METOPROLOL TARTRATE
Active strength 100 mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 84 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A074644-001 METOPROLOL TARTRATE METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 A074644-002 METOPROLOL TARTRATE METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10
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.
Product history page 1 of 3 · 84 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 2026-08-18 06:07:40 2026-07 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METOPROLOL TARTRATE ACTIVE INGREDIENT W5S57Y3A5L METOPROLOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 METOPROLOL ACTIVE MOIETY GEB06NHM23 METOPROLOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METOPROLOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO METOPROLOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X METOPROLOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METOPROLOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A METOPROLOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH METOPROLOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 POVIDONE INACTIVE INGREDIENT FZ989GH94E METOPROLOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METOPROLOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 METOPROLOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 TALC INACTIVE INGREDIENT 7SEV7J4R1U METOPROLOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP METOPROLOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 METOPROLOL TARTRATE ACTIVE INGREDIENT W5S57Y3A5L METOPROLOL TARTRATE TABLET [MED-HEALTH PHARMA, LLC] 3 METOPROLOL ACTIVE MOIETY GEB06NHM23 METOPROLOL TARTRATE TABLET [MED-HEALTH PHARMA, LLC] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METOPROLOL TARTRATE TABLET [MED-HEALTH PHARMA, LLC] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO METOPROLOL TARTRATE TABLET [MED-HEALTH PHARMA, LLC] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X METOPROLOL TARTRATE TABLET [MED-HEALTH PHARMA, LLC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METOPROLOL TARTRATE TABLET [MED-HEALTH PHARMA, LLC] 3 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A METOPROLOL TARTRATE TABLET [MED-HEALTH PHARMA, LLC] 3 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH METOPROLOL TARTRATE TABLET [MED-HEALTH PHARMA, LLC] 3 POVIDONE INACTIVE INGREDIENT FZ989GH94E METOPROLOL TARTRATE TABLET [MED-HEALTH PHARMA, LLC] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METOPROLOL TARTRATE TABLET [MED-HEALTH PHARMA, LLC] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 METOPROLOL TARTRATE TABLET [MED-HEALTH PHARMA, LLC] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U METOPROLOL TARTRATE TABLET [MED-HEALTH PHARMA, LLC] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP METOPROLOL TARTRATE TABLET [MED-HEALTH PHARMA, LLC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57664-162 METOPROLOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 20 Legacy NDC 20240201_6ae551f6-b6cc-46df-b3d7-eb2963295e0a.zip
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 57664-162-52 57664016252 100 TABLET in 1 BOTTLE (57664-162-52) 100 tablet 2015-06-29 0000-00-00 No No Current 57664-162-58 57664016258 1000 TABLET in 1 BOTTLE (57664-162-58) 1000 tablet 2015-06-29 0000-00-00 No No Current 57664-162-59 57664016259 90 TABLET in 1 BOTTLE (57664-162-59) 90 tablet 2015-06-29 0000-00-00 No No Current