Application 075151

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MAGNESIUM SULFATE	MAGNESIUM SULFATE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	5GM/10ML (500MG/ML)	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A075151-001	MAGNESIUM SULFATE	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A075151-001	AP

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 · 42 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
2026-08-18 06:07:40	2026-07	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075151-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2000-04-25	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075151-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075151-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075151-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075151-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075151-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075151-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075151-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075151-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075151-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075151-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075151-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075151-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075151-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075151-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075151-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075151-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075151-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075151-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075151-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075151-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075151-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075151-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075151-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075151-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075151-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075151-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075151-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075151-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075151-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075151-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075151-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075151-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075151-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075151-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075151-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075151-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075151-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075151-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075151-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075151-001	AP	1	`e64feba35796…`

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 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
50% MAGNESIUM SULFATE	50% MAGNESIUM SULFATE	HF Acquisition Co. LLC, DBA Health First	7446d09b-10fe-7765-e053-2a91aa0a56a8	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075151 application number: ANDA075151 ndc (product): 51662-1235
Magnesium Sulfate	MAGNESIUM SULFATE	Hospira, Inc.	d4b5863a-efb9-4551-a9ad-2b06e8666d87	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075151 application number: ANDA075151 ndc (product): 0409-1754
Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Henry Schein, Inc.	27a581a3-2342-4cc3-b90f-6c739bdf7120	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075151 application number: ANDA075151 ndc (product): 0404-9903

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9903	Magnesium Sulfate	Magnesium Sulfate Heptahydrate	Henry Schein, Inc.	ANDA	Current
0404-9903	Magnesium Sulfate	Magnesium Sulfate Heptahydrate	Henry Schein, Inc.	ANDA	Current
0409-1754	Magnesium Sulfate	magnesium sulfate	Hospira, Inc.	ANDA	Current
0409-1754	Magnesium Sulfate	magnesium sulfate	Hospira, Inc.	ANDA	Current
0409-1754	Magnesium Sulfate	magnesium sulfate	Hospira, Inc.	ANDA	Current
0409-1754	Magnesium Sulfate	magnesium sulfate	Hospira, Inc.	ANDA	Current
0409-1754	Magnesium Sulfate	magnesium sulfate	Hospira, Inc.	ANDA	Current
51662-1235	50% MAGNESIUM SULFATE	50% MAGNESIUM SULFATE	HF Acquisition Co. LLC, DBA Health First	ANDA	Current
51662-1235	50% MAGNESIUM SULFATE	50% MAGNESIUM SULFATE	HF Acquisition Co. LLC, DBA Health First	ANDA	Current
51662-1235	50% MAGNESIUM SULFATE	50% MAGNESIUM SULFATE	HF Acquisition Co. LLC, DBA Health First	ANDA	Current
51662-1235	50% MAGNESIUM SULFATE	50% MAGNESIUM SULFATE	HF Acquisition Co. LLC, DBA Health First	ANDA	Current
51662-1235	50% MAGNESIUM SULFATE	50% MAGNESIUM SULFATE	HF Acquisition Co. LLC, DBA Health First	ANDA	Current
52584-754	Magnesium Sulfate	Magnesium Sulfate Heptahydrate	General Injectables & Vaccines, Inc	ANDA	Current
52584-754	Magnesium Sulfate	Magnesium Sulfate Heptahydrate	General Injectables & Vaccines, Inc	ANDA	Current
52584-754	Magnesium Sulfate	Magnesium Sulfate Heptahydrate	General Injectables & Vaccines, Inc	ANDA	Current
52584-754	Magnesium Sulfate	Magnesium Sulfate Heptahydrate	General Injectables & Vaccines, Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30775	ORIG	2000-04-25