Magnesium Sulfate

Product NDC: 66298-1070
11-digit product format: 662981070
Labeler code: 66298
Product ID: 66298-1070_55c630dc-955a-0ce4-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MAGNESIUM SULFATE HEPTAHYDRATE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi Norge AS
Application: ANDA206485
Marketing category: ANDA
Marketing start: 2017-08-01
Marketing end: 0000-00-00
Substance: MAGNESIUM SULFATE HEPTAHYDRATE
Active strength: 80 mg/mL
Pharmacologic classes: Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A206485-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15
A206485-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15
A206485-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15
A206485-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15
A206485-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A206485-001	AP
A206485-002	AP
A206485-003	AP
A206485-004	AP
A206485-005	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 6 · 210 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
2026-08-18 06:07:40	2026-07	A206485-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206485-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206485-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206485-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206485-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206485-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206485-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206485-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206485-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206485-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206485-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206485-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206485-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206485-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206485-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206485-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206485-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206485-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206485-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206485-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206485-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206485-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206485-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206485-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206485-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206485-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206485-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206485-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206485-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206485-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206485-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206485-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206485-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206485-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206485-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206485-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206485-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206485-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206485-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206485-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 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	A206485-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206485-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206485-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206485-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206485-005	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206485-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206485-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206485-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206485-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206485-005	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206485-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206485-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206485-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206485-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206485-005	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206485-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206485-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206485-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206485-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206485-005	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206485-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206485-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206485-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206485-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206485-005	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206485-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206485-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206485-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206485-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206485-005	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206485-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206485-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206485-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206485-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206485-005	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206485-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206485-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206485-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206485-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206485-005	AP	1	`2680178bc6a6…`

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
magnesium sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	fef9e18c-5210-4090-b564-4950ebe461c0	2024-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206485 application number: ANDA206485
magnesium sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	43d658b1-2b19-44be-a346-cac11fd600b3	2024-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206485 application number: ANDA206485
MAGNESIUM SULFATE	MAGNESIUM SULFATE	HF Acquisition Co LLC, DBA HealthFirst	9947731b-fb0f-0c68-e053-2a95a90a815e	2022-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206485 application number: ANDA206485

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66298-1070-5	66298107005	50 mL in 1 BAG (66298-1070-5)	50 ml	2017-08-02	0000-00-00	No	No	Current