Magnesium Sulfate

Product NDC: 52584-754
Requested package NDC: 52584-754-10
11-digit product format: 525840754
Labeler code: 52584
Product ID: 52584-754_32b9244c-5dce-4eb0-a80d-d644d161bf84
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Magnesium Sulfate Heptahydrate
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: General Injectables & Vaccines, Inc
Application: ANDA075151
Marketing category: ANDA
Marketing start: 2010-08-01
Marketing end: 2024-02-01
Substance: MAGNESIUM SULFATE HEPTAHYDRATE
Active strength: 500 mg/mL
Pharmacologic classes: Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52584-754	52584-754-10	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Magnesium Sulfate Heptahydrate	ACTIVE INGREDIENT	SK47B8698T	MAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	2
Magnesium Cation	ACTIVE MOIETY	T6V3LHY838	MAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	2

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
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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SK47B8698T	MAGNESIUM SULFATE HEPTAHYDRATE	10034-99-8	MAGNESIUM SULFATE HEPTAHYDRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
52584-754-10	52584075410	1 SYRINGE, PLASTIC in 1 BAG (52584-754-10) > 10 mL in 1 SYRINGE, PLASTIC	2010-08-01	2024-02-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
50% Magnesium Sulfate 5 g/mL Injection, USP 10 mL PreFilled Syringe Ansyr Plastic Syringe Rx Only	General Injectables & Vaccines, Inc	2022-12-27	HUMAN PRESCRIPTION DRUG LABEL	10