Magnesium Sulfate

Product NDC: 84549-064
11-digit product format: 845490064
Labeler code: 84549
Product ID: 84549-064_386d55c9-aead-5597-e063-6294a90a0afe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MAGNESIUM SULFATE HEPTAHYDRATE
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: ProPharma Distribution
Application: NDA019316
Marketing category: NDA
Marketing start: 2000-08-08
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019316-001	MAGNESIUM SULFATE	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08
N019316-002	MAGNESIUM SULFATE	MAGNESIUM SULFATE	1GM/2ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08
N019316-003	MAGNESIUM SULFATE	MAGNESIUM SULFATE	10GM/20ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29
N019316-004	MAGNESIUM SULFATE	MAGNESIUM SULFATE	25GM/50ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N019316-001	AP
N019316-002	AP
N019316-003	AP
N019316-004	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 5 · 164 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
2026-02-19 14:30 UTC	2026-02	N019316-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019316-002	MAGNESIUM SULFATE	1GM/2ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019316-003	MAGNESIUM SULFATE	10GM/20ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019316-004	MAGNESIUM SULFATE	25GM/50ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019316-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019316-002	MAGNESIUM SULFATE	1GM/2ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019316-003	MAGNESIUM SULFATE	10GM/20ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019316-004	MAGNESIUM SULFATE	25GM/50ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019316-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019316-002	MAGNESIUM SULFATE	1GM/2ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019316-003	MAGNESIUM SULFATE	10GM/20ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019316-004	MAGNESIUM SULFATE	25GM/50ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019316-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019316-002	MAGNESIUM SULFATE	1GM/2ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	1986-09-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019316-003	MAGNESIUM SULFATE	10GM/20ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019316-004	MAGNESIUM SULFATE	25GM/50ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2016-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019316-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019316-002	MAGNESIUM SULFATE	1GM/2ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	1986-09-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019316-003	MAGNESIUM SULFATE	10GM/20ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019316-004	MAGNESIUM SULFATE	25GM/50ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2016-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019316-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019316-002	MAGNESIUM SULFATE	1GM/2ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	1986-09-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019316-003	MAGNESIUM SULFATE	10GM/20ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019316-004	MAGNESIUM SULFATE	25GM/50ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2016-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019316-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019316-002	MAGNESIUM SULFATE	1GM/2ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	1986-09-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019316-003	MAGNESIUM SULFATE	10GM/20ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019316-004	MAGNESIUM SULFATE	25GM/50ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2016-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019316-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019316-002	MAGNESIUM SULFATE	1GM/2ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	1986-09-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019316-003	MAGNESIUM SULFATE	10GM/20ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019316-004	MAGNESIUM SULFATE	25GM/50ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2016-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019316-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019316-002	MAGNESIUM SULFATE	1GM/2ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	1986-09-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019316-003	MAGNESIUM SULFATE	10GM/20ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019316-004	MAGNESIUM SULFATE	25GM/50ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2016-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019316-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019316-002	MAGNESIUM SULFATE	1GM/2ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	1986-09-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019316-003	MAGNESIUM SULFATE	10GM/20ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019316-004	MAGNESIUM SULFATE	25GM/50ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2016-01-29	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019316-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019316-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019316-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019316-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019316-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019316-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019316-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019316-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019316-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019316-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019316-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019316-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019316-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019316-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019316-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019316-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019316-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019316-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019316-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019316-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019316-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019316-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019316-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019316-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019316-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019316-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019316-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019316-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019316-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019316-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019316-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019316-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019316-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019316-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019316-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019316-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019316-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019316-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019316-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019316-003	AP	1	`4b0b4de00fa7…`

Additional Listing Data#

Finished product: Yes
Brand name base: Magnesium Sulfate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MAGNESIUM SULFATE HEPTAHYDRATE	500 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SK47B8698T	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1658244	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
386d55c9-aeac-5597-e063-6294a90a0afe	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6e3c022f-0786-43f1-8857-edff89d5153f	Product name	1	20260309
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
efd58652-cb8f-4018-91ca-4b0eb2ff729f	Product name	7	20240226
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62	Product name	3	20210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
e7e58cd3-cacb-49df-8d34-1ee335614abb	Product name	1	20150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84549-064-03	Magnesium Sulfate	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	2		1
84549-064-11	Magnesium Sulfate	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	10		1

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 · 13 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	e921a46b-9a5b-4163-9c88-224247541f14	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019316 application number: NDA019316
Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	e9c10579-29f3-4889-8881-0626f63968d4	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019316 application number: NDA019316
Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	6a5d362b-7aa7-40d3-898d-09407cce0713	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019316 application number: NDA019316
Magnesium Sulfate	MAGNESIUM SULFATE	Henry Schein, Inc.	c255b8a9-68da-49c1-897b-bc18b731e459	2025-10-31	Warnings	Exact identifier application applno (NDA): 019316 application number: NDA019316
Magnesium Sulfate	MAGNESIUM SULFATE	Henry Schein, Inc.	5176ed24-015e-43fe-9eb4-85098debf5f1	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019316 application number: NDA019316
Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	ProPharma Distribution	3f003556-d675-1cf9-e063-6294a90a2cc4	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019316 application number: NDA019316 ndc (product): 84549-064
Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	REMEDYREPACK INC.	8c6b8b3d-9c04-4ed7-86b8-89065b6bf50d	2025-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019316 application number: NDA019316
Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	ProPharma Distribution	386d55c9-aeac-5597-e063-6294a90a0afe	2025-06-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019316 application number: NDA019316 ndc (product): 84549-064
Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Medical Purchasing Solutions, LLC	7978a5b6-0d9c-499e-e053-2a91aa0a06ad	2023-05-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019316 application number: NDA019316
MAGNESIUM SULFATE	MAGNESIUM SULFATE	HF Acquisition Co LLC, DBA HealthFirst	945419b8-6184-f4f3-e053-2a95a90a6236	2023-01-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019316 application number: NDA019316
MAGNESIUM SULFATE	MAGNESIUM SULFATE	HF Acquisition Co LLC, DBA HealthFirst	94e9a33f-39c4-4bc5-e053-2a95a90a43ac	2022-12-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019316 application number: NDA019316
Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	77f70e00-3934-4fd9-a581-4cf3df8c42d2	2021-12-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019316 application number: NDA019316
Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Medical Purchasing Solutions, LLC	b6352fbd-d3ee-2d3a-e053-2a95a90a747d	2020-12-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019316 application number: NDA019316

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1658244	magnesium sulfate 5 GM in 10 ML Injection	PSN	386d55c9-aeac-5597-e063-6294a90a0afe	1
1658244	magnesium sulfate 5 GM in 10 ML Injection	PSN	3f003556-d675-1cf9-e063-6294a90a2cc4	1
1658244	10 ML magnesium sulfate 500 MG/ML Injection	SCD	386d55c9-aeac-5597-e063-6294a90a0afe	1
1658244	10 ML magnesium sulfate 500 MG/ML Injection	SCD	3f003556-d675-1cf9-e063-6294a90a2cc4	1
1658244	magnesium sulfate 5 GM per 10 ML Injection	SY	386d55c9-aeac-5597-e063-6294a90a0afe	1
1658244	magnesium sulfate 5 GM per 10 ML Injection	SY	3f003556-d675-1cf9-e063-6294a90a2cc4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84549-064-03	84549006403	2 mL in 1 VIAL, SINGLE-DOSE (84549-064-03)	2 ml	2025-06-25	No	No	Current
84549-064-11	84549006411	10 mL in 1 VIAL, SINGLE-DOSE (84549-064-11)	10 ml	2025-09-17	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Magnesium Sulfate Injection, USP	ProPharma Distribution	2025-09-17	HUMAN PRESCRIPTION DRUG LABEL	1
Magnesium Sulfate Injection, USP	ProPharma Distribution	2025-06-25	HUMAN PRESCRIPTION DRUG LABEL	1