Magnesium Sulfate

Product NDC
52584-642
Requested package NDC
52584-642-20
11-digit product format
525840642
Labeler code
52584
Product ID
52584-642_512e413b-44a6-4d26-bec7-5ddeb563f1fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Magnesium Sulfate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
General Injectables and Vaccines, Inc.
Application
NDA019316
Marketing category
NDA
Marketing start
2017-01-13
Marketing end
2024-02-29
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52584-64252584-642-20DDiscontinued by firm2026-08-07

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019316-001MAGNESIUM SULFATEMAGNESIUM SULFATE5GM/10ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS1986-09-08
N019316-002MAGNESIUM SULFATEMAGNESIUM SULFATE1GM/2ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS1986-09-08
N019316-003MAGNESIUM SULFATEMAGNESIUM SULFATE10GM/20ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2016-01-29
N019316-004MAGNESIUM SULFATEMAGNESIUM SULFATE25GM/50ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2016-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N019316-001AP
N019316-002AP
N019316-003AP
N019316-004AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N019316-001MAGNESIUM SULFATE5GM/10ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS1986-09-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019316-002MAGNESIUM SULFATE1GM/2ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS1986-09-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019316-003MAGNESIUM SULFATE10GM/20ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2016-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019316-004MAGNESIUM SULFATE25GM/50ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2016-01-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019316-001MAGNESIUM SULFATE5GM/10ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS1986-09-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019316-002MAGNESIUM SULFATE1GM/2ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS1986-09-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019316-003MAGNESIUM SULFATE10GM/20ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2016-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019316-004MAGNESIUM SULFATE25GM/50ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2016-01-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N019316-001MAGNESIUM SULFATE5GM/10ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS1986-09-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019316-002MAGNESIUM SULFATE1GM/2ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS1986-09-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019316-003MAGNESIUM SULFATE10GM/20ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2016-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019316-004MAGNESIUM SULFATE25GM/50ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2016-01-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019316-001MAGNESIUM SULFATE5GM/10ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS1986-09-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019316-002MAGNESIUM SULFATE1GM/2ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS1986-09-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019316-003MAGNESIUM SULFATE10GM/20ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2016-01-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019316-004MAGNESIUM SULFATE25GM/50ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2016-01-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019316-001MAGNESIUM SULFATE5GM/10ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS1986-09-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019316-002MAGNESIUM SULFATE1GM/2ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS1986-09-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019316-003MAGNESIUM SULFATE10GM/20ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2016-01-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019316-004MAGNESIUM SULFATE25GM/50ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2016-01-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019316-001MAGNESIUM SULFATE5GM/10ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS1986-09-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019316-002MAGNESIUM SULFATE1GM/2ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS1986-09-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019316-003MAGNESIUM SULFATE10GM/20ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2016-01-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019316-004MAGNESIUM SULFATE25GM/50ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2016-01-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019316-001MAGNESIUM SULFATE5GM/10ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS1986-09-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019316-002MAGNESIUM SULFATE1GM/2ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS1986-09-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019316-003MAGNESIUM SULFATE10GM/20ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2016-01-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019316-004MAGNESIUM SULFATE25GM/50ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2016-01-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019316-001MAGNESIUM SULFATE5GM/10ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS1986-09-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019316-002MAGNESIUM SULFATE1GM/2ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS1986-09-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019316-003MAGNESIUM SULFATE10GM/20ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2016-01-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019316-004MAGNESIUM SULFATE25GM/50ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2016-01-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019316-001MAGNESIUM SULFATE5GM/10ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS1986-09-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019316-002MAGNESIUM SULFATE1GM/2ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS1986-09-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019316-003MAGNESIUM SULFATE10GM/20ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2016-01-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019316-004MAGNESIUM SULFATE25GM/50ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2016-01-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019316-001MAGNESIUM SULFATE5GM/10ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS1986-09-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N019316-002MAGNESIUM SULFATE1GM/2ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS1986-09-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N019316-003MAGNESIUM SULFATE10GM/20ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2016-01-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N019316-004MAGNESIUM SULFATE25GM/50ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2016-01-29d06236e962d9…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N019316-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019316-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019316-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019316-004AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019316-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019316-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019316-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019316-004AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019316-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019316-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019316-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019316-004AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019316-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019316-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019316-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019316-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019316-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019316-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019316-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019316-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019316-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019316-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019316-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019316-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019316-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019316-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019316-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019316-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019316-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019316-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019316-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019316-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019316-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N019316-003AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019316-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019316-003AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019316-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019316-003AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019316-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019316-003AP14b0b4de00fa7…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEFresenius Kabi USA, LLCe921a46b-9a5b-4163-9c88-224247541f142026-01-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 019316
application number: NDA019316
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEFresenius Kabi USA, LLCe9c10579-29f3-4889-8881-0626f63968d42026-01-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 019316
application number: NDA019316
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEFresenius Kabi USA, LLC6a5d362b-7aa7-40d3-898d-09407cce07132026-01-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 019316
application number: NDA019316
Magnesium SulfateMAGNESIUM SULFATEHenry Schein, Inc.c255b8a9-68da-49c1-897b-bc18b731e4592025-10-31WarningsExact identifier
application applno (NDA): 019316
application number: NDA019316
Magnesium SulfateMAGNESIUM SULFATEHenry Schein, Inc.5176ed24-015e-43fe-9eb4-85098debf5f12025-10-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 019316
application number: NDA019316
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEProPharma Distribution3f003556-d675-1cf9-e063-6294a90a2cc42025-09-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 019316
application number: NDA019316
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEREMEDYREPACK INC.8c6b8b3d-9c04-4ed7-86b8-89065b6bf50d2025-06-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 019316
application number: NDA019316
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEProPharma Distribution386d55c9-aeac-5597-e063-6294a90a0afe2025-06-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 019316
application number: NDA019316
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEMedical Purchasing Solutions, LLC7978a5b6-0d9c-499e-e053-2a91aa0a06ad2023-05-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 019316
application number: NDA019316
MAGNESIUM SULFATEMAGNESIUM SULFATEHF Acquisition Co LLC, DBA HealthFirst945419b8-6184-f4f3-e053-2a95a90a62362023-01-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 019316
application number: NDA019316
MAGNESIUM SULFATEMAGNESIUM SULFATEHF Acquisition Co LLC, DBA HealthFirst94e9a33f-39c4-4bc5-e053-2a95a90a43ac2022-12-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 019316
application number: NDA019316
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEFresenius Kabi USA, LLC77f70e00-3934-4fd9-a581-4cf3df8c42d22021-12-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 019316
application number: NDA019316
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEMedical Purchasing Solutions, LLCb6352fbd-d3ee-2d3a-e053-2a95a90a747d2020-12-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 019316
application number: NDA019316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52584-642-20525840642201 VIAL, SINGLE-DOSE in 1 BAG (52584-642-20) > 20 mL in 1 VIAL, SINGLE-DOSE2017-01-132024-02-29NoNoCurrent