Magnesium Sulfate in Water

Product NDC
44567-424
11-digit product format
445670424
Labeler code
44567
Product ID
44567-424_142db107-b377-48f0-9a75-88bfbb5b24a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Magnesium Sulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
ANDA207350
Marketing category
ANDA
Marketing start
2018-01-09
Substance
MAGNESIUM SULFATE HEPTAHYDRATE
Active strength
4 g/50mL
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207350-001MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATE2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06
A207350-002MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATE4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06
A207350-003MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATE4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2017-12-06
A207350-004MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATE20GM/500ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06
A207350-005MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATE40GM/1000ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207350-001AP
A207350-002AP
A207350-003AP
A207350-004AP
A207350-005AP

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 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A207350-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-0684e616aacf4f…
2026-09-14 22:38:342026-08A207350-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-0684e616aacf4f…
2026-09-14 22:38:342026-08A207350-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2017-12-0684e616aacf4f…
2026-09-14 22:38:342026-08A207350-004MAGNESIUM SULFATE IN PLASTIC CONTAINER20GM/500ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-0684e616aacf4f…
2026-09-14 22:38:342026-08A207350-005MAGNESIUM SULFATE IN PLASTIC CONTAINER40GM/1000ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-0684e616aacf4f…
2026-08-18 06:07:402026-07A207350-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06caaa826d4ba7…
2026-08-18 06:07:402026-07A207350-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06caaa826d4ba7…
2026-08-18 06:07:402026-07A207350-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2017-12-06caaa826d4ba7…
2026-08-18 06:07:402026-07A207350-004MAGNESIUM SULFATE IN PLASTIC CONTAINER20GM/500ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06caaa826d4ba7…
2026-08-18 06:07:402026-07A207350-005MAGNESIUM SULFATE IN PLASTIC CONTAINER40GM/1000ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207350-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207350-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207350-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2017-12-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207350-004MAGNESIUM SULFATE IN PLASTIC CONTAINER20GM/500ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207350-005MAGNESIUM SULFATE IN PLASTIC CONTAINER40GM/1000ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207350-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207350-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207350-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2017-12-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207350-004MAGNESIUM SULFATE IN PLASTIC CONTAINER20GM/500ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207350-005MAGNESIUM SULFATE IN PLASTIC CONTAINER40GM/1000ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A207350-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207350-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207350-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2017-12-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207350-004MAGNESIUM SULFATE IN PLASTIC CONTAINER20GM/500ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207350-005MAGNESIUM SULFATE IN PLASTIC CONTAINER40GM/1000ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207350-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207350-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207350-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2017-12-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207350-004MAGNESIUM SULFATE IN PLASTIC CONTAINER20GM/500ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207350-005MAGNESIUM SULFATE IN PLASTIC CONTAINER40GM/1000ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207350-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207350-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207350-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2017-12-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207350-004MAGNESIUM SULFATE IN PLASTIC CONTAINER20GM/500ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207350-005MAGNESIUM SULFATE IN PLASTIC CONTAINER40GM/1000ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207350-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207350-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207350-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2017-12-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207350-004MAGNESIUM SULFATE IN PLASTIC CONTAINER20GM/500ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207350-005MAGNESIUM SULFATE IN PLASTIC CONTAINER40GM/1000ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-0603ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207350-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207350-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207350-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207350-004AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207350-005AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207350-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207350-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207350-003AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207350-004AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207350-005AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207350-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207350-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207350-003AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207350-004AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207350-005AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207350-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207350-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207350-003AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207350-004AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207350-005AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207350-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207350-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207350-003AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207350-004AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207350-005AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207350-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207350-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207350-003AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207350-004AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207350-005AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207350-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207350-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207350-003AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207350-004AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207350-005AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207350-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207350-002AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207350-003AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207350-004AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207350-005AP18072bd15b7f6…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM SULFATE HEPTAHYDRATE4 g/50mL

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
44567-424-24Magnesium Sulfate in Water24 in 1 CARTONINJECTION2411
44567-424-24Magnesium Sulfate in Water1 in 1 POUCHINJECTION111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-424-24ML - Milliliter44567-424daf07b81-56a5-46a2-ad4c-fee5a235c8c612021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-424MAGNESIUM SULFATE IN WATER (MAGNESIUM SULFATE) INJECTION [WG CRITICAL CARE, LLC]11Current NDC, Legacy NDC, 2 package rows20240203_752f55bb-c4ca-4545-94b3-3deea66888d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658259magnesium sulfate 2 GM in 50 ML InjectionPSN752f55bb-c4ca-4545-94b3-3deea66888d411
1658264magnesium sulfate 20 GM in 500 ML InjectionPSN752f55bb-c4ca-4545-94b3-3deea66888d411
1658262magnesium sulfate 4 GM in 100 ML InjectionPSN752f55bb-c4ca-4545-94b3-3deea66888d411
829734magnesium sulfate 4 GM in 50 ML InjectionPSN752f55bb-c4ca-4545-94b3-3deea66888d411
1658265magnesium sulfate 40 GM in 1000 ML InjectionPSN752f55bb-c4ca-4545-94b3-3deea66888d411
1658262100 ML magnesium sulfate 40 MG/ML InjectionSCD752f55bb-c4ca-4545-94b3-3deea66888d411
16582651000 ML magnesium sulfate 40 MG/ML InjectionSCD752f55bb-c4ca-4545-94b3-3deea66888d411
165825950 ML magnesium sulfate 40 MG/ML InjectionSCD752f55bb-c4ca-4545-94b3-3deea66888d411
82973450 ML magnesium sulfate 80 MG/ML InjectionSCD752f55bb-c4ca-4545-94b3-3deea66888d411
1658264500 ML magnesium sulfate 40 MG/ML InjectionSCD752f55bb-c4ca-4545-94b3-3deea66888d411
1658259magnesium sulfate 2 GM per 50 ML InjectionSY752f55bb-c4ca-4545-94b3-3deea66888d411
1658264magnesium sulfate 20 GM per 500 ML InjectionSY752f55bb-c4ca-4545-94b3-3deea66888d411
1658262magnesium sulfate 4 GM per 100 ML InjectionSY752f55bb-c4ca-4545-94b3-3deea66888d411
829734magnesium sulfate 4 GM per 50 ML InjectionSY752f55bb-c4ca-4545-94b3-3deea66888d411
1658265magnesium sulfate 40 GM per 1000 ML InjectionSY752f55bb-c4ca-4545-94b3-3deea66888d411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44567-424-244456704242424 POUCH in 1 CARTON (44567-424-24) / 1 BAG in 1 POUCH / 50 mL in 1 BAG24 pouch2018-01-090000-00-00NoNoCurrent