Home NDC 70934-351 Metoprolol Tartrate
Product NDC 70934-351
11-digit product format 709340351
Labeler code 70934
Product ID 70934-351_c45989f7-77c1-4bc5-e053-2995a90a09a7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metoprolol Tartrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application ANDA200981
Marketing category ANDA
Marketing start 2019-05-02
Marketing end 0000-00-00
Substance METOPROLOL TARTRATE
Active strength 50 mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
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 1 · 7 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 A200981-001 METOPROLOL TARTRATE METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2014-10-28 A200981-002 METOPROLOL TARTRATE METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2014-10-28 A200981-003 METOPROLOL TARTRATE METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2014-10-28 A200981-004 METOPROLOL TARTRATE METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2019-08-21 A200981-005 METOPROLOL TARTRATE METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2019-08-21
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 6 · 211 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 A200981-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2014-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200981-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2014-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200981-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2014-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200981-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2019-08-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200981-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2019-08-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A200981-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2014-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200981-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2014-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200981-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2014-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200981-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2019-08-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200981-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2019-08-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200981-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2014-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200981-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2014-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200981-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2014-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200981-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2019-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200981-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2019-08-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200981-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2014-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200981-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2014-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200981-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2014-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200981-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2019-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200981-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2019-08-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200981-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2014-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200981-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2014-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200981-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2014-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200981-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2019-08-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200981-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2019-08-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200981-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2014-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200981-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2014-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200981-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2014-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200981-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2019-08-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200981-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2019-08-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200981-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2014-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200981-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2014-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200981-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2014-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200981-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2019-08-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200981-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2019-08-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200981-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2014-10-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200981-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2014-10-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200981-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2014-10-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200981-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2019-08-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200981-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2019-08-21 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 211 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 70934-351-30 2023-02-02 METOPROLOL TARTRATE TABLETS, USP TruPharma LLC R x only 70934-351-60 2023-02-02 METOPROLOL TARTRATE TABLETS, USP TruPharma LLC R x only 70934-351-90 2023-02-02 METOPROLOL TARTRATE TABLETS, USP TruPharma LLC R x only 70934-351-96 2023-02-02 METOPROLOL TARTRATE TABLETS, USP TruPharma LLC R x only 70934-351-30 2023-01-30 METOPROLOL TARTRATE TABLETS, USP TruPharma LLC R x only 70934-351-60 2023-01-30 METOPROLOL TARTRATE TABLETS, USP TruPharma LLC R x only 70934-351-90 2023-01-30 METOPROLOL TARTRATE TABLETS, USP TruPharma LLC R x only 70934-351-96 2023-01-30 METOPROLOL TARTRATE TABLETS, USP TruPharma LLC R x only
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70934-351 METOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS] 4 Legacy NDC 20230203_8a97e594-95f7-3aae-e053-2995a90a1b41.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 5 of 5 · 82 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70934-351-30 70934035130 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-351-30) 2019-05-02 0000-00-00 No No Current 70934-351-60 70934035160 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-351-60) 2021-06-09 0000-00-00 No No Current 70934-351-90 70934035190 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-351-90) 2021-06-11 0000-00-00 No No Current 70934-351-96 70934035196 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-351-96) 2019-05-02 0000-00-00 No No Current