Application 075160

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METOPROLOL TARTRATE	METOPROLOL TARTRATE	INJECTABLE;INJECTION	1MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075160-001	METOPROLOL TARTRATE	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION			1998-07-06

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		1998-07-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		1998-07-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		1998-07-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		1998-07-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		1998-07-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		1998-07-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		1998-07-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		1998-07-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		1998-07-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		1998-07-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		1998-07-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		1998-07-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		1998-07-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		1998-07-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		1998-07-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		1998-07-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	1998-07-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	1998-07-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	1998-07-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	1998-07-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	1998-07-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	1998-07-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	1998-07-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	1998-07-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	1998-07-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	1998-07-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	1998-07-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	1998-07-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	1998-07-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		1998-07-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		1998-07-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		1998-07-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		1998-07-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		1998-07-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION		1998-07-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	1998-07-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	1998-07-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	1998-07-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	1998-07-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075160-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	1998-07-06	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075160-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075160-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075160-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075160-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075160-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075160-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075160-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075160-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075160-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075160-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075160-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075160-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075160-001	AP	1	`ea99ee380514…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075160-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075160-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075160-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075160-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075160-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075160-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075160-001	AP	1	`cb3db0bc1861…`

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 2 of 9 · 171 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METOPROLOL TARTRATE	METOPROLOL TARTRATE	St. Mary's Medical Park Pharmacy	3bc7d371-6057-a9dc-e063-6394a90a6a9c	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Preferred Pharmaceuticals Inc.	5fd16fbd-be05-49aa-86a9-0f775c1b5a37	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Preferred Pharmaceuticals Inc.	9af11192-61fa-44b8-86eb-3a5e68ec1747	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Preferred Pharmaceuticals, Inc.	b4d1e5ba-f1a8-4c77-bd65-db8e9342370b	2026-06-25	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL	REMEDYREPACK INC.	e1c99d45-8f42-46b1-b770-14d0eb2b300a	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	St. Mary's Medical Park Pharmacy	e3de73ee-bcc7-ba40-e053-2a95a90a8f8f	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Preferred Pharmaceuticals Inc.	35922e9c-6a4c-446a-8294-a4cd3f3f0d10	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	54754388-39c9-9a02-e063-6394a90a90b3	2026-06-17	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	5466243e-1e3d-175e-e063-6394a90a5dee	2026-06-16	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	REMEDYREPACK INC.	ad7a07a1-a05f-4eee-ba0a-69675ffbb6e8	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	REMEDYREPACK INC.	fae7a662-9b27-4c5f-80b5-22442f0ae436	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Cardinal Health 107, LLC	a670d75a-ec69-4570-a3be-c57b896fc553	2026-06-05	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	REMEDYREPACK INC.	5987a15b-e86f-4fd7-a377-35a917c0e3fe	2026-06-05	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Direct_Rx	5371c1af-93fa-39db-e063-6394a90a6111	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	St. Mary's Medical Park Pharmacy	e55cd5b5-c739-24ba-e053-2995a90a3ed4	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Hospira, Inc.	7c1f998a-233d-4feb-6ea2-457702abd0d2	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	PD-Rx Pharmaceuticals, Inc.	ab44f4c5-9497-4c92-8545-e4718ddb8f08	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	REMEDYREPACK INC.	f7a05d74-f5e9-4236-a967-c57942a2bbf3	2026-05-20	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	522c3807-855e-20a3-e063-6394a90abeb7	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	522cc739-1252-4689-e063-6294a90ad1b0	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-2285	Metoprolol Tartrate	METOPROLOL TARTRATE	Hospira, Inc.	ANDA	Current
0409-2285	Metoprolol Tartrate	METOPROLOL TARTRATE	Hospira, Inc.	ANDA	Current
52584-285	Metoprolol Tartrate	Metoprolol Tartrate	General Injectables & Vaccines, Inc	ANDA	Current
55154-4726	Metoprolol Tartrate	Metoprolol Tartrate	Cardinal Health	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42951	ORIG	2002-09-25
8544	ORIG	1998-07-06