Metoprolol Injectable Solution
- Brand(s)
- Lopressor
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Novartis Pharmaceuticals Corporation (2015-07-07)
- Oldest Current Product
- 1978-01-15
- License(s)
- NDA, ANDA
- RxNORM
- INJECTABLE SOLUTION\METOPROLOL
- FDAOB
- INJECTION\INJECTION\METOPROLOL TARTRATE\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, SOLUTION\METOPROLOL TARTRATE
INTRAVENOUS\INJECTION\METOPROLOL TARTRATE - SPL Moiety
- INTRAVENOUS\INJECTION, SOLUTION\METOPROLOL
INTRAVENOUS\INJECTION\METOPROLOL
product(s) by strength(s)
metoprolol tartrate 1 mg/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000780400 | Lopressor | NDA | Novartis Pharmaceuticals Corporation | 1978-01-15 | METOPROLOL TARTRATE | INTRAVENOUS | INJECTION, SOLUTION | NDA018704 | 6640cc61-edee-4808-a26f-cbc2c0b7af86 |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 001439660 | ANDA | West-Ward Pharmaceutical Corp | 2007-05-30 | METOPROLOL TARTRATE | INTRAVENOUS | INJECTION, SOLUTION | ANDA077761 | c7ec36bb-bc6f-42de-9974-a50ac13e9410 |
| 2 | 001439873 | ANDA | West-Ward Pharmaceutical Corp | 2007-05-30 | METOPROLOL TARTRATE | INTRAVENOUS | INJECTION, SOLUTION | ANDA077761 | c7ec36bb-bc6f-42de-9974-a50ac13e9410 |
| 3 | 004091778 | ANDA | Hospira, Inc. | 1993-12-21, 2008-04-29 | METOPROLOL TARTRATE | INTRAVENOUS | INJECTION, SOLUTION | ANDA074133, ANDA078085 | 5554af64-cb12-4712-6391-a4212842804a, 7c1f998a-233d-4feb-6ea2-457702abd0d2 |
| 4 | 004092285 | ANDA | Hospira, Inc. | 1998-07-06 | METOPROLOL TARTRATE | INTRAVENOUS | INJECTION, SOLUTION | ANDA075160 | 5554af64-cb12-4712-6391-a4212842804a |
| 5 | 005171355 | ANDA | American Regent, Inc. | 2010-02-11 | METOPROLOL TARTRATE | INTRAVENOUS | INJECTION, SOLUTION | ANDA090386 | 6063ba4d-d03a-488d-b937-70b3a32b7114 |
| 6 | 007813071 | ANDA | Sandoz Inc | 2007-10-02 | METOPROLOL TARTRATE | INTRAVENOUS | INJECTION, SOLUTION | ANDA077360 | 0d451179-d5de-4832-95a1-baf02ed34b3e |
| 7 | 250210303 | ANDA | Sagent Pharmaceuticals | 2010-05-10 | METOPROLOL TARTRATE | INTRAVENOUS | INJECTION | ANDA090317 | f3817543-544a-4afa-ac7c-c1b48c1307c2 |
| 8 | 360000033 | ANDA | Claris Lifesciences Inc. | 2012-09-25 | METOPROLOL TARTRATE | INTRAVENOUS | INJECTION | ANDA078950 | 09566368-f91d-43a3-b683-30c844fb125a |
| 9 | 633230660 | ANDA | App Pharmaceuticals, Llc | 2010-10-28 | METOPROLOL TARTRATE | INTRAVENOUS | INJECTION, SOLUTION | ANDA091045 | be1c686e-37a5-4a53-945b-68a6ead35134 |
| 10 | 680830131 | ANDA | Gland Pharma Limited | 2014-10-06 | METOPROLOL TARTRATE | INTRAVENOUS | INJECTION | ANDA204205 | e89cb5ec-e11b-4ca9-b3e3-34a4f144d7fe |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 525840285 | ANDA | General Injecatables & Vaccines, Inc | 2010-08-01 | METOPROLOL TARTRATE | INTRAVENOUS | INJECTION, SOLUTION | 004092285 | ANDA075160 | 91666161-880e-4a69-95f0-6f18314ea999 |
| 2 | 548685726 | ANDA | Physicians Total Care, Inc. | 2006-12-11 | METOPROLOL TARTRATE | INTRAVENOUS | INJECTION, SOLUTION | 55390007310 | ANDA076495 | 5d167858-0567-4414-a437-c577569212d9 |
| 3 | 551540373 | ANDA | Cardinal Health | 2008-05-05 | METOPROLOL TARTRATE | INTRAVENOUS | INJECTION, SOLUTION | 553900348 | ANDA076495 | 903d2fe0-87b7-43f8-98a4-693f61f9e6b5 |
| 4 | 551542355 | ANDA | Cardinal Health | 1998-07-06 | METOPROLOL TARTRATE | INTRAVENOUS | INJECTION, SOLUTION | 004092285 | ANDA075160 | 805857e0-2560-4a09-ba2d-e78d9024b180 |
| 5 | 551544451 | ANDA | Cardinal Health | 2012-09-25 | METOPROLOL TARTRATE | INTRAVENOUS | INJECTION | 360000033 | ANDA078950 | d6ae40f1-bc7d-4d3a-b2e9-8d4fc4d1d759 |
| 6 | 551544726 | ANDA | Cardinal Health | 1998-07-06 | METOPROLOL TARTRATE | INTRAVENOUS | INJECTION, SOLUTION | 004092285 | ANDA075160 | ffd837ea-551d-4b98-96e1-80c29ac32b20 |
| 7 | 551544745 | ANDA | Cardinal Health | 2008-04-29 | METOPROLOL TARTRATE | INTRAVENOUS | INJECTION, SOLUTION | 004091778 | ANDA078085 | a670d75a-ec69-4570-a3be-c57b896fc553 |
| 8 | 551545741 | ANDA | Cardinal Health | 2010-02-11 | METOPROLOL TARTRATE | INTRAVENOUS | INJECTION, SOLUTION | 005171355 | ANDA090386 | 61ce2a92-df17-4994-bea0-edda0d6774bc |
| 9 | 551547460 | ANDA | Cardinal Health | 2007-05-30 | METOPROLOL TARTRATE | INTRAVENOUS | INJECTION, SOLUTION | 001439873 | ANDA077761 | 0c69c289-1271-415f-92cb-5296ac6d8c1c |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA074032 | METOPROLOL TARTRATE | True | WATSON LABORATORIES INC | 1993-12-21 | ANDA074032_001 |
| 2 | ANDA074133 | METOPROLOL TARTRATE | HOSPIRA INC | 1993-12-21 | ANDA074133_001 | |
| 3 | ANDA075160 | METOPROLOL TARTRATE | HOSPIRA INC | 1998-07-06 | ANDA075160_001 | |
| 4 | ANDA076495 | METOPROLOL TARTRATE | BEDFORD LABORATORIES | 2003-07-07 | ANDA076495_001 | |
| 5 | ANDA077360 | METOPROLOL TARTRATE | SANDOZ CANADA INC | 2007-10-02 | ANDA077360_001 | |
| 6 | ANDA077761 | METOPROLOL TARTRATE | HIKMA FARMACEUTICA (PORTUGAL) SA | 2007-05-30 | ANDA077761_001 | |
| 7 | ANDA078085 | METOPROLOL TARTRATE | HOSPIRA INC | 2008-04-29 | ANDA078085_001 | |
| 8 | ANDA078950 | METOPROLOL TARTRATE | CLARIS PHARMASERVICES | 2013-04-29 | ANDA078950_001 | |
| 9 | ANDA090317 | METOPROLOL TARTRATE | SAGENT STRIDES LLC | 2010-04-19 | ANDA090317_001 | |
| 10 | ANDA090386 | METOPROLOL TARTRATE | LUITPOLD PHARMACEUTICALS INC | 2009-09-30 | ANDA090386_001 | |
| 11 | ANDA091045 | METOPROLOL TARTRATE | FRESENIUS KABI USA LLC | 2010-10-25 | ANDA091045_001 | |
| 12 | ANDA091307 | METOPROLOL TARTRATE | LUITPOLD PHARMACEUTICALS INC | 2010-12-29 | ANDA091307_001 | |
| 13 | ANDA204205 | METOPROLOL TARTRATE | GLAND PHARMA LTD | 2014-08-27 | ANDA204205_001 | |
| 14 | NDA018704 | LOPRESSOR | NOVARTIS PHARMACEUTICALS CORP | 1984-03-30 | NDA018704_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA074032_001 | discontinued | METOPROLOL TARTRATE (1MG/ML) | INJECTION | False | 1993-12-21 | METOPROLOL TARTRATE | |
| 2 | ANDA074133_001 | RX | METOPROLOL TARTRATE (1MG/ML) | INJECTION | False | AP | 1993-12-21 | METOPROLOL TARTRATE |
| 3 | ANDA075160_001 | RX | METOPROLOL TARTRATE (1MG/ML) | INJECTION | False | AP | 1998-07-06 | METOPROLOL TARTRATE |
| 4 | ANDA076495_001 | RX | METOPROLOL TARTRATE (1MG/ML) | INJECTION | False | AP | 2003-07-07 | METOPROLOL TARTRATE |
| 5 | ANDA077360_001 | RX | METOPROLOL TARTRATE (1MG/ML) | INJECTION | False | AP | 2007-10-02 | METOPROLOL TARTRATE |
| 6 | ANDA077761_001 | RX | METOPROLOL TARTRATE (1MG/ML) | INJECTION | False | AP | 2007-05-30 | METOPROLOL TARTRATE |
| 7 | ANDA078085_001 | RX | METOPROLOL TARTRATE (1MG/ML) | INJECTION | False | AP | 2008-04-29 | METOPROLOL TARTRATE |
| 8 | ANDA078950_001 | RX | METOPROLOL TARTRATE (1MG/ML) | INJECTION | False | AP | 2013-04-29 | METOPROLOL TARTRATE |
| 9 | ANDA090317_001 | RX | METOPROLOL TARTRATE (1MG/ML) | INJECTION | False | AP | 2010-04-19 | METOPROLOL TARTRATE |
| 10 | ANDA090386_001 | RX | METOPROLOL TARTRATE (1MG/ML) | INJECTION | False | AP | 2009-09-30 | METOPROLOL TARTRATE |
| 11 | ANDA091045_001 | RX | METOPROLOL TARTRATE (1MG/ML) | INJECTION | False | AP | 2010-10-25 | METOPROLOL TARTRATE |
| 12 | ANDA091307_001 | RX | METOPROLOL TARTRATE (1MG/ML) | INJECTION | False | AP | 2010-12-29 | METOPROLOL TARTRATE |
| 13 | ANDA204205_001 | RX | METOPROLOL TARTRATE (1MG/ML) | INJECTION | False | AP | 2014-08-27 | METOPROLOL TARTRATE |
| 14 | NDA018704_001 | RX | METOPROLOL TARTRATE (1MG/ML) | INJECTION | True | AP | 1984-03-30 | LOPRESSOR |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 09566368-f91d-43a3-b683-30c844fb125a (view SPL) | Metoprolol Tartrate Injection, USP | prescription | Human Prescription | Claris Lifesciences Inc. | MANUFACTURE | 2015-06-29 | 9 | 360000033 |
| 2 | 0c69c289-1271-415f-92cb-5296ac6d8c1c (view SPL) | Metoprolol Tartrate Injection, USP Rx Only | prescription | Human Prescription | Cardinal Health | REPACK | 2013-03-18 | 2 | 551547460 |
| 3 | 0d451179-d5de-4832-95a1-baf02ed34b3e (view SPL) | Metoprolol Tartrate Injection, USP | prescription | Human Prescription | Sandoz Inc | 2013-04-12 | 16 | 007813071 | |
| 4 | 5554af64-cb12-4712-6391-a4212842804a (view SPL) | Metoprolol Tartrate | prescription | Human Prescription | Hospira, Inc. | 2015-10-26 | 14 | 004091778, 004092285 | |
| 5 | 5d167858-0567-4414-a437-c577569212d9 (view SPL) | METOPROLOL TARTRATE INJECTION USP | prescription | Human Prescription | Physicians Total Care, Inc. | relabel | 2009-12-31 | 1 | 548685726 |
| 6 | 6063ba4d-d03a-488d-b937-70b3a32b7114 (view SPL) | METOPROLOL TARTRATE INJECTION, USP | prescription | Human Prescription | American Regent, Inc. | ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE | 2013-08-05 | 6 | 005171355 |
| 7 | 61ce2a92-df17-4994-bea0-edda0d6774bc (view SPL) | METOPROLOL TARTRATE INJECTION, USP | prescription | Human Prescription | Cardinal Health | REPACK | 2013-03-08 | 1 | 551545741 |
| 8 | 6640cc61-edee-4808-a26f-cbc2c0b7af86 (view SPL) | prescription | Human Prescription | Novartis Pharmaceuticals Corporation | 2015-07-07 | 2 | 000780400 | ||
| 9 | 7c1f998a-233d-4feb-6ea2-457702abd0d2 (view SPL) | Metoprolol Tartrate | prescription | Human Prescription | Hospira, Inc. | 2015-10-27 | 15 | 004091778 | |
| 10 | 805857e0-2560-4a09-ba2d-e78d9024b180 (view SPL) | Metoprolol TartrateInjection, USP | prescription | Human Prescription | Cardinal Health | REPACK | 2013-05-20 | 3 | 551542355 |
| 11 | 903d2fe0-87b7-43f8-98a4-693f61f9e6b5 (view SPL) | METOPROLOL TARTRATE INJECTION USP | prescription | Human Prescription | Cardinal Health | REPACK | 2011-05-25 | 1 | 551540373 |
| 12 | 91666161-880e-4a69-95f0-6f18314ea999 (view SPL) | Metoprolol Tartrate Injection, USPRx only | prescription | Human Prescription | General Injecatables & Vaccines, Inc | relabel | 2013-07-26 | 2 | 525840285 |
| 13 | a670d75a-ec69-4570-a3be-c57b896fc553 (view SPL) | Metoprolol Tartrate | prescription | Human Prescription | Cardinal Health | REPACK | 2014-01-20 | 1 | 551544745 |
| 14 | be1c686e-37a5-4a53-945b-68a6ead35134 (view SPL) | Metoprolol Tartrate Injection, USP | prescription | Human Prescription | App Pharmaceuticals, Llc | MANUFACTURE | 2013-09-13 | 3 | 633230660 |
| 15 | c7ec36bb-bc6f-42de-9974-a50ac13e9410 (view SPL) | METOPROLOL TARTRATE INJECTION, USP | prescription | Human Prescription | West-Ward Pharmaceutical Corp | ANALYSIS, LABEL, MANUFACTURE, PACK | 2015-09-22 | 6 | 001439660, 001439873 |
| 16 | d6ae40f1-bc7d-4d3a-b2e9-8d4fc4d1d759 (view SPL) | Metoprolol Tartrate Injection, USP | prescription | Human Prescription | Cardinal Health | REPACK | 2015-08-13 | 2 | 551544451 |
| 17 | e89cb5ec-e11b-4ca9-b3e3-34a4f144d7fe (view SPL) | Metoprolol Tartrate Injection, USP Rx only Prescribing Information | prescription | Human Prescription | Gland Pharma Limited | ANALYSIS, MANUFACTURE | 2014-09-09 | 3 | 680830131 |
| 18 | f3817543-544a-4afa-ac7c-c1b48c1307c2 (view SPL) | Metoprolol Tartrate Injection, USP | prescription | Human Prescription | Sagent Pharmaceuticals | 2013-04-09 | 8 | 250210303 | |
| 19 | ffd837ea-551d-4b98-96e1-80c29ac32b20 (view SPL) | Metoprolol Tartrate | prescription | Human Prescription | Cardinal Health | REPACK | 2014-09-08 | 2 | 551544726 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII