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 3 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	A-S Medication Solutions	ef6a817b-58c5-45bc-b5a2-22c31b05c0ab	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	A-S Medication Solutions	2bcfb9d9-e092-4a0a-ac55-bad532de360c	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	ASCLEMED USA INC.	df3492c3-b71a-40d8-838b-031ebca969d8	2026-05-18	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL	Coupler LLC	512711ea-a3be-6de6-e063-6394a90a9109	2026-05-06	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Hospira, Inc.	f65e93ec-4db6-44fa-bff1-8ae89aa8243f	2026-05-04	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOROPROLOL TARTRATE	Civica, Inc.	8dae76a2-32e7-40a2-bb70-9c6380b9b330	2026-04-19	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate
METOPROLOL TARTRATE	METOPROLOL TARTRATE	NuCare Pharmaceuticals, Inc.	4f9ba91b-ecfc-10cc-e063-6294a90ae236	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	ST. MARY'S MEDICAL PARK PHARMACY	4f845cbb-81a2-72c4-e063-6394a90a96d6	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	QPharma, Inc.	4dcb79e6-19de-67fb-e063-6294a90afde0	2026-04-10	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Bryant Ranch Prepack	840ac287-cae5-4c07-82d5-546fb04414ef	2026-04-09	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Bryant Ranch Prepack	22f1b399-83ad-4c2e-bb17-c11967a7471e	2026-04-09	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL	Proficient Rx LP	95b95aab-0733-4189-b4c0-429a1046c534	2026-04-01	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Redpharm Drug	4ce1c1ef-bc9a-1397-e063-6294a90a3bda	2026-03-13	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	PD-Rx Pharmaceuticals, Inc.	4cdbfc5d-2572-39b0-e063-6394a90af5f2	2026-03-12	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Legacy Pharmaceutical Packaging, LLC	20cc66c0-a00b-4643-9819-6e0daed51e5f	2026-03-11	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Bryant Ranch Prepack	77fb1898-871f-489f-bc0b-933dd08a9bc4	2026-03-11	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Direct_Rx	13b7404f-e16b-5d43-e063-6394a90a3fca	2026-03-05	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Exelan Pharmaceuticals, Inc.	f54b250d-bd15-483b-b191-a664291382c1	2026-02-27	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	A-S Medication Solutions	e1bb16fa-4f72-44bc-bc33-d7653c13f55c	2026-02-04	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	A-S Medication Solutions	5b423eba-0a35-41b0-9338-fa4c6f5c6c7f	2026-02-04	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