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 4 of 9 · 171 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metoprolol	METOPROLOL TARTRATE	Fresenius Kabi USA, LLC	ccb1a15e-c943-4042-ae46-550bdabfc96b	2026-02-02	Warnings, Adverse reactions	Name fallback generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Direct_Rx	499ce022-12a7-e4e5-e063-6394a90a435a	2026-01-30	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Advagen Pharma Limited	d62a972a-bc45-4582-9701-bed27a1a9e4d	2026-01-29	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
LOPRESSOR	METOPROLOL TARTRATE	VALIDUS PHARMACEUTICALS LLC	b5f4fed2-369c-4808-a682-8a5b8cfdbb4f	2026-01-26	Warnings, Adverse reactions	Name fallback generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	PD-Rx Pharmaceuticals, Inc.	18f44ba2-d431-4a73-ac78-83e734fde694	2026-01-16	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Advagen Pharma Limited	a401fe31-d51a-49d9-a062-c9d22088db56	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	PD-Rx Pharmaceuticals, Inc.	d3628f24-8076-4980-a358-8445ef8260f4	2026-01-12	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Direct_Rx	3bb62867-cf85-ce6d-e063-6294a90ad17f	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	PD-Rx Pharmaceuticals, Inc.	19678edf-934a-45f3-b5da-94d10e9b3248	2026-01-07	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL	NuCare Pharmaceuticals, Inc.	47d11c0c-82dd-33b1-e063-6394a90a6a97	2026-01-07	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	NuCare Pharmaceuticals, Inc.	47d18ba7-558d-1190-e063-6294a90a958f	2026-01-07	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Northwind Health Company, LLC	e07d2929-7f78-cf63-e053-2995a90af82b	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Northwind Health Company, LLC	f318d14a-9f96-4238-e053-2995a90abc15	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Northwind Health Company, LLC	f319e981-81ff-22da-e053-2a95a90a2738	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Northwind Health Company, LLC	d9cbda2a-70d9-74d3-e053-2a95a90aacc1	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Northwind Health Company, LLC	d9df7d01-339c-8985-e053-2a95a90a0d2c	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Proficient Rx LP	0c8e58ab-c755-4560-b7f5-0dbd5e81a0b8	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Coupler LLC	4616db7f-2c2f-96a5-e063-6394a90a939f	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	NuCare Pharmaceuticals, Inc.	4604cd40-f96f-42bf-e063-6294a90a308f	2025-12-15	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	QPharma Inc	2ad0606c-7a90-44bd-a75d-d256de30fbcf	2025-12-05	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