Home NDC 12634-771 Metoprolol Tartrate
Product NDC 12634-771
11-digit product format 126340771
Labeler code 12634
Product ID 12634-771_467a6c4f-8634-5686-e054-00144ff8d46c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metoprolol Tartrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Apotheca Inc.
Application ANDA077739
Marketing category ANDA
Marketing start 2007-09-11
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 2020-12-31
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 11 · 624 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 172 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 A077739-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2007-09-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077739-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2007-09-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077739-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2007-09-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077739-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2023-12-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077739-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2023-12-07 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 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# NDC, Related label table NDC Related label 12634-771-00 Metoprolol Tartrate Tablets, USP Rx only 12634-771-01 Metoprolol Tartrate Tablets, USP Rx only 12634-771-09 Metoprolol Tartrate Tablets, USP Rx only 12634-771-12 Metoprolol Tartrate Tablets, USP Rx only 12634-771-18 Metoprolol Tartrate Tablets, USP Rx only 12634-771-40 Metoprolol Tartrate Tablets, USP Rx only 12634-771-42 Metoprolol Tartrate Tablets, USP Rx only 12634-771-45 Metoprolol Tartrate Tablets, USP Rx only 12634-771-50 Metoprolol Tartrate Tablets, USP Rx only 12634-771-52 Metoprolol Tartrate Tablets, USP Rx only 12634-771-54 Metoprolol Tartrate Tablets, USP Rx only 12634-771-57 Metoprolol Tartrate Tablets, USP Rx only 12634-771-59 Metoprolol Tartrate Tablets, USP Rx only 12634-771-60 Metoprolol Tartrate Tablets, USP Rx only 12634-771-61 Metoprolol Tartrate Tablets, USP Rx only 12634-771-63 Metoprolol Tartrate Tablets, USP Rx only 12634-771-66 Metoprolol Tartrate Tablets, USP Rx only 12634-771-67 Metoprolol Tartrate Tablets, USP Rx only 12634-771-69 Metoprolol Tartrate Tablets, USP Rx only 12634-771-71 Metoprolol Tartrate Tablets, USP Rx only 12634-771-74 Metoprolol Tartrate Tablets, USP Rx only 12634-771-78 Metoprolol Tartrate Tablets, USP Rx only 12634-771-79 Metoprolol Tartrate Tablets, USP Rx only 12634-771-80 Metoprolol Tartrate Tablets, USP Rx only 12634-771-81 Metoprolol Tartrate Tablets, USP Rx only 12634-771-82 Metoprolol Tartrate Tablets, USP Rx only 12634-771-84 Metoprolol Tartrate Tablets, USP Rx only 12634-771-85 Metoprolol Tartrate Tablets, USP Rx only 12634-771-90 Metoprolol Tartrate Tablets, USP Rx only 12634-771-91 Metoprolol Tartrate Tablets, USP Rx only 12634-771-92 Metoprolol Tartrate Tablets, USP Rx only 12634-771-93 Metoprolol Tartrate Tablets, USP Rx only 12634-771-94 Metoprolol Tartrate Tablets, USP Rx only 12634-771-95 Metoprolol Tartrate Tablets, USP Rx only 12634-771-96 Metoprolol Tartrate Tablets, USP Rx only 12634-771-97 Metoprolol Tartrate Tablets, USP Rx only 12634-771-98 Metoprolol Tartrate Tablets, USP Rx only 12634-771-99 Metoprolol Tartrate Tablets, USP Rx only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 12634-771-00 Metoprolol Tartrate 10 in 1 BOTTLE TABLET, FILM COATED 10 1 12634-771-01 Metoprolol Tartrate 100 in 1 BOTTLE TABLET, FILM COATED 100 1 12634-771-09 Metoprolol Tartrate 35 in 1 BOTTLE TABLET, FILM COATED 35 1 12634-771-12 Metoprolol Tartrate 120 in 1 BOTTLE TABLET, FILM COATED 120 1 12634-771-18 Metoprolol Tartrate 180 in 1 BOTTLE TABLET, FILM COATED 180 1 12634-771-40 Metoprolol Tartrate 40 in 1 BOTTLE TABLET, FILM COATED 40 1 12634-771-42 Metoprolol Tartrate 42 in 1 BOTTLE TABLET, FILM COATED 42 1 12634-771-45 Metoprolol Tartrate 45 in 1 BOTTLE TABLET, FILM COATED 45 1 12634-771-50 Metoprolol Tartrate 50 in 1 BOTTLE TABLET, FILM COATED 50 1 12634-771-52 Metoprolol Tartrate 12 in 1 BLISTER PACK TABLET, FILM COATED 12 1 12634-771-54 Metoprolol Tartrate 14 in 1 BLISTER PACK TABLET, FILM COATED 14 1 12634-771-57 Metoprolol Tartrate 20 in 1 BLISTER PACK TABLET, FILM COATED 20 1 12634-771-59 Metoprolol Tartrate 30 in 1 BLISTER PACK TABLET, FILM COATED 30 1 12634-771-60 Metoprolol Tartrate 60 in 1 BOTTLE TABLET, FILM COATED 60 1 12634-771-61 Metoprolol Tartrate 10 in 1 BLISTER PACK TABLET, FILM COATED 10 1 12634-771-63 Metoprolol Tartrate 3 in 1 BLISTER PACK TABLET, FILM COATED 3 1 12634-771-66 Metoprolol Tartrate 6 in 1 BLISTER PACK TABLET, FILM COATED 6 1 12634-771-67 Metoprolol Tartrate 7 in 1 BLISTER PACK TABLET, FILM COATED 7 1 12634-771-69 Metoprolol Tartrate 9 in 1 BLISTER PACK TABLET, FILM COATED 9 1 12634-771-71 Metoprolol Tartrate 30 in 1 BOTTLE TABLET, FILM COATED 30 1 12634-771-74 Metoprolol Tartrate 24 in 1 BOTTLE TABLET, FILM COATED 24 1 12634-771-78 Metoprolol Tartrate 28 in 1 BOTTLE TABLET, FILM COATED 28 1 12634-771-79 Metoprolol Tartrate 25 in 1 BOTTLE TABLET, FILM COATED 25 1 12634-771-80 Metoprolol Tartrate 20 in 1 BOTTLE TABLET, FILM COATED 20 1 12634-771-81 Metoprolol Tartrate 21 in 1 BOTTLE TABLET, FILM COATED 21 1 12634-771-82 Metoprolol Tartrate 12 in 1 BOTTLE TABLET, FILM COATED 12 1 12634-771-84 Metoprolol Tartrate 14 in 1 BOTTLE TABLET, FILM COATED 14 1 12634-771-85 Metoprolol Tartrate 15 in 1 BOTTLE TABLET, FILM COATED 15 1 12634-771-90 Metoprolol Tartrate 90 in 1 BOTTLE TABLET, FILM COATED 90 1 12634-771-91 Metoprolol Tartrate 1 in 1 BLISTER PACK TABLET, FILM COATED 1 1 12634-771-92 Metoprolol Tartrate 2 in 1 BOTTLE TABLET, FILM COATED 2 1 12634-771-93 Metoprolol Tartrate 3 in 1 BOTTLE TABLET, FILM COATED 3 1 12634-771-94 Metoprolol Tartrate 4 in 1 BOTTLE TABLET, FILM COATED 4 1 12634-771-95 Metoprolol Tartrate 5 in 1 BOTTLE TABLET, FILM COATED 5 1 12634-771-96 Metoprolol Tartrate 6 in 1 BOTTLE TABLET, FILM COATED 6 1 12634-771-97 Metoprolol Tartrate 7 in 1 BOTTLE TABLET, FILM COATED 7 1 12634-771-98 Metoprolol Tartrate 8 in 1 BOTTLE TABLET, FILM COATED 8 1 12634-771-99 Metoprolol Tartrate 9 in 1 BOTTLE TABLET, FILM COATED 9 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 12634-771 METOPROLOL TARTRATE TABLET, FILM COATED [APOTHECA INC.] 1 Legacy NDC, 38 package rows 20170120_467a6c4f-8633-5686-e054-00144ff8d46c.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 Marketing start Marketing end Sample Exclude flag Status 12634-771-00 12634077100 10 TABLET, FILM COATED in 1 BOTTLE (12634-771-00) 2007-09-11 0000-00-00 No No Current 12634-771-01 12634077101 100 TABLET, FILM COATED in 1 BOTTLE (12634-771-01) 2007-09-11 0000-00-00 No No Current 12634-771-09 12634077109 35 TABLET, FILM COATED in 1 BOTTLE (12634-771-09) 2007-09-11 0000-00-00 No No Current 12634-771-12 12634077112 120 TABLET, FILM COATED in 1 BOTTLE (12634-771-12) 2007-09-11 0000-00-00 No No Current 12634-771-18 12634077118 180 TABLET, FILM COATED in 1 BOTTLE (12634-771-18) 2007-09-11 0000-00-00 No No Current 12634-771-40 12634077140 40 TABLET, FILM COATED in 1 BOTTLE (12634-771-40) 2007-09-11 0000-00-00 No No Current 12634-771-42 12634077142 42 TABLET, FILM COATED in 1 BOTTLE (12634-771-42) 2007-09-11 0000-00-00 No No Current 12634-771-45 12634077145 45 TABLET, FILM COATED in 1 BOTTLE (12634-771-45) 2007-09-11 0000-00-00 No No Current 12634-771-50 12634077150 50 TABLET, FILM COATED in 1 BOTTLE (12634-771-50) 2007-09-11 0000-00-00 No No Current 12634-771-52 12634077152 12 TABLET, FILM COATED in 1 BLISTER PACK (12634-771-52) 2007-09-11 0000-00-00 No No Current 12634-771-54 12634077154 14 TABLET, FILM COATED in 1 BLISTER PACK (12634-771-54) 2007-09-11 0000-00-00 No No Current 12634-771-57 12634077157 20 TABLET, FILM COATED in 1 BLISTER PACK (12634-771-57) 2007-09-11 0000-00-00 No No Current 12634-771-59 12634077159 30 TABLET, FILM COATED in 1 BLISTER PACK (12634-771-59) 2007-09-11 0000-00-00 No No Current 12634-771-60 12634077160 60 TABLET, FILM COATED in 1 BOTTLE (12634-771-60) 2007-09-11 0000-00-00 No No Current 12634-771-61 12634077161 10 TABLET, FILM COATED in 1 BLISTER PACK (12634-771-61) 2007-09-11 0000-00-00 No No Current 12634-771-63 12634077163 3 TABLET, FILM COATED in 1 BLISTER PACK (12634-771-63) 2007-09-11 0000-00-00 No No Current 12634-771-66 12634077166 6 TABLET, FILM COATED in 1 BLISTER PACK (12634-771-66) 2007-09-11 0000-00-00 No No Current 12634-771-67 12634077167 7 TABLET, FILM COATED in 1 BLISTER PACK (12634-771-67) 2007-09-11 0000-00-00 No No Current 12634-771-69 12634077169 9 TABLET, FILM COATED in 1 BLISTER PACK (12634-771-69) 2007-09-11 0000-00-00 No No Current 12634-771-71 12634077171 30 TABLET, FILM COATED in 1 BOTTLE (12634-771-71) 2007-09-11 0000-00-00 No No Current 12634-771-74 12634077174 24 TABLET, FILM COATED in 1 BOTTLE (12634-771-74) 2007-09-11 0000-00-00 No No Current 12634-771-78 12634077178 28 TABLET, FILM COATED in 1 BOTTLE (12634-771-78) 2007-09-11 0000-00-00 No No Current 12634-771-79 12634077179 25 TABLET, FILM COATED in 1 BOTTLE (12634-771-79) 2007-09-11 0000-00-00 No No Current 12634-771-80 12634077180 20 TABLET, FILM COATED in 1 BOTTLE (12634-771-80) 2007-09-11 0000-00-00 No No Current 12634-771-81 12634077181 21 TABLET, FILM COATED in 1 BOTTLE (12634-771-81) 2007-09-11 0000-00-00 No No Current 12634-771-82 12634077182 12 TABLET, FILM COATED in 1 BOTTLE (12634-771-82) 2007-09-11 0000-00-00 No No Current 12634-771-84 12634077184 14 TABLET, FILM COATED in 1 BOTTLE (12634-771-84) 2007-09-11 0000-00-00 No No Current 12634-771-85 12634077185 15 TABLET, FILM COATED in 1 BOTTLE (12634-771-85) 2007-09-11 0000-00-00 No No Current 12634-771-90 12634077190 90 TABLET, FILM COATED in 1 BOTTLE (12634-771-90) 2007-09-11 0000-00-00 No No Current 12634-771-91 12634077191 1 TABLET, FILM COATED in 1 BLISTER PACK (12634-771-91) 2007-09-11 0000-00-00 No No Current 12634-771-92 12634077192 2 TABLET, FILM COATED in 1 BOTTLE (12634-771-92) 2007-09-11 0000-00-00 No No Current 12634-771-93 12634077193 3 TABLET, FILM COATED in 1 BOTTLE (12634-771-93) 2007-09-11 0000-00-00 No No Current 12634-771-94 12634077194 4 TABLET, FILM COATED in 1 BOTTLE (12634-771-94) 2007-09-11 0000-00-00 No No Current 12634-771-95 12634077195 5 TABLET, FILM COATED in 1 BOTTLE (12634-771-95) 2007-09-11 0000-00-00 No No Current 12634-771-96 12634077196 6 TABLET, FILM COATED in 1 BOTTLE (12634-771-96) 2007-09-11 0000-00-00 No No Current 12634-771-97 12634077197 7 TABLET, FILM COATED in 1 BOTTLE (12634-771-97) 2007-09-11 0000-00-00 No No Current 12634-771-98 12634077198 8 TABLET, FILM COATED in 1 BOTTLE (12634-771-98) 2007-09-11 0000-00-00 No No Current 12634-771-99 12634077199 9 TABLET, FILM COATED in 1 BOTTLE (12634-771-99) 2007-09-11 0000-00-00 No No Current