FDA.reportPublic FDA data

Magnesium Sulfate in Water

Product NDC
44567-170
11-digit product format
445670170
Labeler code
44567
Product ID
44567-170_952000af-f58d-4762-b806-443cbdda0168
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
2 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 4 of 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2020-12-22 03:56 UTC2020-12A207350-001AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A207350-002AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A207350-003AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A207350-004AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A207350-005AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207350-001AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A207350-002AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A207350-003AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A207350-004AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A207350-005AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207350-001AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A207350-002AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A207350-003AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A207350-004AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A207350-005AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A207350-001AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A207350-002AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A207350-003AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A207350-004AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A207350-005AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207350-001AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A207350-002AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A207350-003AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A207350-004AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A207350-005AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207350-001AP16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207350-002AP16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207350-003AP16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207350-004AP16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207350-005AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207350-001AP11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A207350-002AP11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A207350-003AP11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A207350-004AP11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A207350-005AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207350-001AP1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A207350-002AP1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A207350-003AP1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A207350-004AP1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A207350-005AP1ea1830bbd6c7…

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 HEPTAHYDRATE2 g/50mL

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
44567-170-244456701702424 POUCH in 1 CARTON (44567-170-24) / 1 BAG in 1 POUCH (44567-170-01) / 50 mL in 1 BAG24 pouch2018-01-09NoNoCurrent