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 3 of 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207350-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207350-002AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207350-003AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207350-004AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207350-005AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207350-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207350-002AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207350-003AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207350-004AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207350-005AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207350-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207350-002AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207350-003AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207350-004AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207350-005AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207350-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207350-002AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207350-003AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207350-004AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207350-005AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207350-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207350-002AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207350-003AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207350-004AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207350-005AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207350-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A207350-002AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A207350-003AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A207350-004AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A207350-005AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207350-001AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207350-002AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207350-003AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207350-004AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207350-005AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A207350-001AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A207350-002AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A207350-003AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A207350-004AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A207350-005AP15aa47cf7b7d7…

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