Magnesium Sulfate

Product NDC
63323-064
11-digit product format
633230064
Labeler code
63323
Product ID
63323-064_ac877c06-691b-4bc1-830b-8f4403d526d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MAGNESIUM SULFATE HEPTAHYDRATE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
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
2027-12-31
Current FDA listing
Yes

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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63323-064DDiscontinued by firm2026-08-11
excluded productproduct63323-064DDiscontinued by firm2026-08-11
excluded packagepackage63323-06463323-064-20DDiscontinued by firm2026-08-11
excluded packagepackage63323-06463323-064-50DDiscontinued by firm2026-08-11
excluded packagepackage63323-06463323-064-29DDiscontinued by firm2026-08-11
excluded packagepackage63323-06463323-064-26DDiscontinued by firm2026-08-11
excluded packagepackage63323-06463323-064-02DDiscontinued by firm2026-08-11
excluded packagepackage63323-06463323-064-10DDiscontinued by firm2026-08-11

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 2 · 72 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63323-064-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63323-064-29d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63323-064-26d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63323-064-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63323-064-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63323-064-29f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63323-064-26f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63323-064-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63323-064-502ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63323-064-292ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63323-064-262ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63323-064-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63323-064-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63323-064-29a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63323-064-26a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63323-064-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63323-064-50cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63323-064-29cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63323-064-26cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63323-064-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63323-064-50cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63323-064-29cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63323-064-26cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63323-064-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63323-064-50302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63323-064-29302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63323-064-26302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63323-064-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63323-064-50ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63323-064-29ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63323-064-26ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63323-064-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63323-064-500efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63323-064-290efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63323-064-260efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63323-064-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63323-064-50ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63323-064-29ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63323-064-26ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63323-064-20ad56d346431e…cc804d4bbf1e…

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Magnesium Sulfate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM SULFATE HEPTAHYDRATE500 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SK47B8698TInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1658221Internal RxNorm lookup
1658244Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6a5d362b-7aa7-40d3-898d-09407cce0713Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-064-01Magnesium Sulfate2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION29
63323-064-02Magnesium Sulfate2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION29
63323-064-02Magnesium Sulfate25 in 1 TRAYINJECTION, SOLUTION259
63323-064-03Magnesium Sulfate25 in 1 CARTONINJECTION, SOLUTION259
63323-064-04Magnesium Sulfate10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION109
63323-064-10Magnesium Sulfate10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION109
63323-064-10Magnesium Sulfate25 in 1 TRAYINJECTION, SOLUTION259
63323-064-11Magnesium Sulfate25 in 1 TRAYINJECTION, SOLUTION259
63323-064-21Magnesium Sulfate2 mL in 1 VIAL, GLASSINJECTION, SOLUTION25
63323-064-23Magnesium Sulfate25 in 1 TRAYINJECTION, SOLUTION255
63323-064-26Magnesium Sulfate25 in 1 TRAYINJECTION, SOLUTION255
63323-064-26Magnesium Sulfate2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION25
63323-064-41Magnesium Sulfate2 mL in 1 VIAL, GLASSINJECTION, SOLUTION25
63323-064-43Magnesium Sulfate25 in 1 TRAYINJECTION, SOLUTION255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-064-01ML - Milliliter63323-064388deca7-0986-493c-ba69-084125e6204812018-03-08
63323-064-02ML - Milliliter63323-0646dfaff0d-fabf-40b1-a08b-b10f9b25f14312013-02-13
63323-064-03ML - Milliliter63323-064fa799104-7303-46b1-bb57-f50d6175ab1712018-02-20
63323-064-04ML - Milliliter63323-06404083129-98c0-4e71-a18d-d60c5966cc6312018-03-08
63323-064-09ML - Milliliter63323-0641fac92e9-edc3-42a5-8e60-c72a22d52ecc12014-09-03
63323-064-10ML - Milliliter63323-064faa84df3-78d5-4ac4-baa3-b8b36e7ef91312013-02-13
63323-064-11ML - Milliliter63323-064b5c53d6b-a0ed-474c-b06c-b5c8078038a812018-02-20
63323-064-20ML - Milliliter63323-0642a548f11-c480-46f6-bc4a-75d82a8f2a6c12013-02-13
63323-064-21ML - Milliliter63323-064ee03d12c-5823-45bd-9cc4-409282daf8f012021-04-08
63323-064-23ML - Milliliter63323-0643251c497-6019-4164-b143-97e78cd4191412018-12-13
63323-064-26ML - Milliliter63323-064ebdb991c-8220-4ef8-a732-792c9725857a12016-06-14
63323-064-29ML - Milliliter63323-064580772df-ab40-477d-a095-fcb26472a28912014-09-03
63323-064-41ML - Milliliter63323-064fa24f111-1557-47f2-aafc-39104aef158412018-07-03
63323-064-43ML - Milliliter63323-064d0632775-134d-4d96-affb-36ab0520820112018-07-03
63323-064-50ML - Milliliter63323-064e16e4422-4cc6-4c4b-86e5-c58f498b363112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MAGNESIUM SULFATE HEPTAHYDRATEACTIVE INGREDIENTSK47B8698TMAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838MAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFMAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
MAGNESIUM SULFATE HEPTAHYDRATEACTIVE INGREDIENTSK47B8698TMAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
MAGNESIUM SULFATE HEPTAHYDRATEACTIVE INGREDIENTSK47B8698TMAGNESIUM SULFATE INJECTION, SOLUTION [GENERAL INJECTABLES AND VACCINES, INC.]1
MAGNESIUM SULFATE HEPTAHYDRATEACTIVE INGREDIENTSK47B8698TMAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838MAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838MAGNESIUM SULFATE INJECTION, SOLUTION [GENERAL INJECTABLES AND VACCINES, INC.]1
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838MAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMAGNESIUM SULFATE INJECTION, SOLUTION [GENERAL INJECTABLES AND VACCINES, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFMAGNESIUM SULFATE INJECTION, SOLUTION [GENERAL INJECTABLES AND VACCINES, INC.]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFMAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-064MAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]7Current NDC, Legacy NDC, 8 package rows20231109_e9c10579-29f3-4889-8881-0626f63968d4.zip
63323-064MAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 2 package rows20210320_e921a46b-9a5b-4163-9c88-224247541f14.zip
63323-064MAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 4 package rows20210320_6a5d362b-7aa7-40d3-898d-09407cce0713.zip

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
ndc (product): 63323-064
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEFresenius Kabi USA, LLCe9c10579-29f3-4889-8881-0626f63968d42026-01-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 019316
application number: NDA019316
ndc (product): 63323-064
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEFresenius Kabi USA, LLC6a5d362b-7aa7-40d3-898d-09407cce07132026-01-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 019316
application number: NDA019316
ndc (product): 63323-064
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658221magnesium sulfate 1 GM in 2 ML InjectionPSNe9c10579-29f3-4889-8881-0626f63968d49
1658244magnesium sulfate 5 GM in 10 ML InjectionPSNe9c10579-29f3-4889-8881-0626f63968d49
165824410 ML magnesium sulfate 500 MG/ML InjectionSCDe9c10579-29f3-4889-8881-0626f63968d49
16582212 ML magnesium sulfate 500 MG/ML InjectionSCDe9c10579-29f3-4889-8881-0626f63968d49
1658221magnesium sulfate 1 GM per 2 ML InjectionSYe9c10579-29f3-4889-8881-0626f63968d49
1658244magnesium sulfate 5 GM per 10 ML InjectionSYe9c10579-29f3-4889-8881-0626f63968d49
1658221magnesium sulfate 1 GM in 2 ML InjectionPSN6a5d362b-7aa7-40d3-898d-09407cce07135
1658221magnesium sulfate 1 GM in 2 ML InjectionPSNe921a46b-9a5b-4163-9c88-224247541f145
1658221magnesium sulfate 1 GM in 2 ML InjectionPSN5176ed24-015e-43fe-9eb4-85098debf5f15
1658244magnesium sulfate 5 GM in 10 ML InjectionPSN6a5d362b-7aa7-40d3-898d-09407cce07135
1658244magnesium sulfate 5 GM in 10 ML InjectionPSNe921a46b-9a5b-4163-9c88-224247541f145
165824410 ML magnesium sulfate 500 MG/ML InjectionSCD6a5d362b-7aa7-40d3-898d-09407cce07135
165824410 ML magnesium sulfate 500 MG/ML InjectionSCDe921a46b-9a5b-4163-9c88-224247541f145
16582212 ML magnesium sulfate 500 MG/ML InjectionSCD5176ed24-015e-43fe-9eb4-85098debf5f15
16582212 ML magnesium sulfate 500 MG/ML InjectionSCD6a5d362b-7aa7-40d3-898d-09407cce07135
16582212 ML magnesium sulfate 500 MG/ML InjectionSCDe921a46b-9a5b-4163-9c88-224247541f145
1658221magnesium sulfate 1 GM per 2 ML InjectionSY6a5d362b-7aa7-40d3-898d-09407cce07135
1658221magnesium sulfate 1 GM per 2 ML InjectionSY5176ed24-015e-43fe-9eb4-85098debf5f15
1658221magnesium sulfate 1 GM per 2 ML InjectionSYe921a46b-9a5b-4163-9c88-224247541f145
1658244magnesium sulfate 5 GM per 10 ML InjectionSY6a5d362b-7aa7-40d3-898d-09407cce07135
1658244magnesium sulfate 5 GM per 10 ML InjectionSYe921a46b-9a5b-4163-9c88-224247541f145
1658221magnesium sulfate 1 GM in 2 ML InjectionPSN945419b8-6184-f4f3-e053-2a95a90a62363
1658244magnesium sulfate 5 GM in 10 ML InjectionPSN9970acda-3a9a-7e5d-e053-2995a90a25d33
165824410 ML magnesium sulfate 500 MG/ML InjectionSCD9970acda-3a9a-7e5d-e053-2995a90a25d33
16582212 ML magnesium sulfate 500 MG/ML InjectionSCD945419b8-6184-f4f3-e053-2a95a90a62363
1658221magnesium sulfate 1 GM per 2 ML InjectionSY945419b8-6184-f4f3-e053-2a95a90a62363
1658244magnesium sulfate 5 GM per 10 ML InjectionSY9970acda-3a9a-7e5d-e053-2995a90a25d33
1658244magnesium sulfate 5 GM in 10 ML InjectionPSNb6352fbd-d3ee-2d3a-e053-2a95a90a747d1
1658244magnesium sulfate 5 GM in 10 ML InjectionPSN8c6b8b3d-9c04-4ed7-86b8-89065b6bf50d1
1658244magnesium sulfate 5 GM in 10 ML InjectionPSN3f003556-d675-1cf9-e063-6294a90a2cc41
1658244magnesium sulfate 5 GM in 10 ML InjectionPSN386d55c9-aeac-5597-e063-6294a90a0afe1
165824410 ML magnesium sulfate 500 MG/ML InjectionSCDb6352fbd-d3ee-2d3a-e053-2a95a90a747d1
165824410 ML magnesium sulfate 500 MG/ML InjectionSCD8c6b8b3d-9c04-4ed7-86b8-89065b6bf50d1
165824410 ML magnesium sulfate 500 MG/ML InjectionSCD3f003556-d675-1cf9-e063-6294a90a2cc41
165824410 ML magnesium sulfate 500 MG/ML InjectionSCD386d55c9-aeac-5597-e063-6294a90a0afe1
1658244magnesium sulfate 5 GM per 10 ML InjectionSYb6352fbd-d3ee-2d3a-e053-2a95a90a747d1
1658244magnesium sulfate 5 GM per 10 ML InjectionSY386d55c9-aeac-5597-e063-6294a90a0afe1
1658244magnesium sulfate 5 GM per 10 ML InjectionSY8c6b8b3d-9c04-4ed7-86b8-89065b6bf50d1
1658244magnesium sulfate 5 GM per 10 ML InjectionSY3f003556-d675-1cf9-e063-6294a90a2cc41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-064-01633230064012 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
63323-064-02633230064022 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
63323-064-036332300640325 VIAL, SINGLE-DOSE in 1 CARTON (63323-064-03) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-064-01) 2000-08-080000-00-00NoNoCurrent
63323-064-046332300640410 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
63323-064-106332300641010 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
63323-064-116332300641125 VIAL, SINGLE-DOSE in 1 TRAY (63323-064-11) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-064-04) 2000-08-080000-00-00NoNoCurrent
63323-064-21633230064212 mL in 1 VIAL, GLASS2 mlHistorical
63323-064-236332300642325 VIAL, GLASS in 1 TRAY (63323-064-23) / 2 mL in 1 VIAL, GLASS (63323-064-21) 2000-08-080000-00-00NoNoCurrent
63323-064-266332300642625 in 1 TRAYHistorical
63323-064-41633230064412 mL in 1 VIAL, GLASS2 mlHistorical
63323-064-436332300644325 VIAL, GLASS in 1 TRAY (63323-064-43) / 2 mL in 1 VIAL, GLASS (63323-064-41) 2000-08-080000-00-00NoNoCurrent