Magnesium Sulfate in Water

Product NDC
44567-423
11-digit product format
445670423
Labeler code
44567
Product ID
44567-423_c9d96764-1b44-455e-a3ca-aec9d889004e
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
40 g/1000mL
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 42.

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 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207350-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207350-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207350-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2017-12-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207350-004MAGNESIUM SULFATE IN PLASTIC CONTAINER20GM/500ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207350-005MAGNESIUM SULFATE IN PLASTIC CONTAINER40GM/1000ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-062680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A207350-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A207350-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A207350-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A207350-004AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A207350-005AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207350-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207350-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207350-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207350-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207350-005AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207350-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207350-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207350-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207350-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207350-005AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207350-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207350-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207350-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207350-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207350-005AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207350-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207350-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207350-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207350-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207350-005AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207350-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207350-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207350-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207350-004AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207350-005AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207350-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207350-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207350-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207350-004AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207350-005AP103ed91905a0d…
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…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM SULFATE HEPTAHYDRATE40 g/1000mL

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 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
829734Internal RxNorm lookup
1658259Internal RxNorm lookup
1658262Internal RxNorm lookup
1658264Internal RxNorm lookup
1658265Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
752f55bb-c4ca-4545-94b3-3deea66888d4Available 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
44567-423-10Magnesium Sulfate in Water1000 mL in 1 BAGINJECTION100011
44567-423-10Magnesium Sulfate in Water10 in 1 CARTONINJECTION1011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-423MAGNESIUM SULFATE IN WATER (MAGNESIUM SULFATE) INJECTION [WG CRITICAL CARE, LLC]11Current NDC, Legacy NDC, 2 package rows20240203_752f55bb-c4ca-4545-94b3-3deea66888d4.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Magnesium Sulfate in WaterMAGNESIUM SULFATEWG Critical Care, LLC752f55bb-c4ca-4545-94b3-3deea66888d42023-09-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207350
application number: ANDA207350
ndc (product): 44567-423

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
44567-423-104456704231010 BAG in 1 CARTON (44567-423-10) / 1000 mL in 1 BAG10 bag2018-01-090000-00-00NoNoCurrent