Home NDC 44567-421 Magnesium Sulfate in Water
Product NDC 44567-421
11-digit product format 445670421
Labeler code 44567
Product ID 44567-421_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/100mL
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207350-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 A207350-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 A207350-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2017-12-06 A207350-004 MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 20GM/500ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 A207350-005 MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 40GM/1000ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
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 3 of 6 · 215 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207350-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207350-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207350-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2017-12-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207350-004 MAGNESIUM SULFATE IN PLASTIC CONTAINER 20GM/500ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207350-005 MAGNESIUM SULFATE IN PLASTIC CONTAINER 40GM/1000ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207350-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207350-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207350-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2017-12-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207350-004 MAGNESIUM SULFATE IN PLASTIC CONTAINER 20GM/500ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207350-005 MAGNESIUM SULFATE IN PLASTIC CONTAINER 40GM/1000ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207350-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207350-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207350-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2017-12-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207350-004 MAGNESIUM SULFATE IN PLASTIC CONTAINER 20GM/500ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207350-005 MAGNESIUM SULFATE IN PLASTIC CONTAINER 40GM/1000ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207350-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A207350-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A207350-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2017-12-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A207350-004 MAGNESIUM SULFATE IN PLASTIC CONTAINER 20GM/500ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A207350-005 MAGNESIUM SULFATE IN PLASTIC CONTAINER 40GM/1000ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207350-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A207350-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A207350-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2017-12-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A207350-004 MAGNESIUM SULFATE IN PLASTIC CONTAINER 20GM/500ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A207350-005 MAGNESIUM SULFATE IN PLASTIC CONTAINER 40GM/1000ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207350-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A207350-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A207350-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2017-12-06 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A207350-004 MAGNESIUM SULFATE IN PLASTIC CONTAINER 20GM/500ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A207350-005 MAGNESIUM SULFATE IN PLASTIC CONTAINER 40GM/1000ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207350-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207350-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207350-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2017-12-06 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207350-004 MAGNESIUM SULFATE IN PLASTIC CONTAINER 20GM/500ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207350-005 MAGNESIUM SULFATE IN PLASTIC CONTAINER 40GM/1000ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207350-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A207350-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A207350-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2017-12-06 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A207350-004 MAGNESIUM SULFATE IN PLASTIC CONTAINER 20GM/500ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A207350-005 MAGNESIUM SULFATE IN PLASTIC CONTAINER 40GM/1000ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 5aa47cf7b7d7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 215 observed states.
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 Ingredient Strength MAGNESIUM SULFATE HEPTAHYDRATE 4 g/100mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 44567-421-24 Magnesium Sulfate in Water 24 in 1 CARTON INJECTION 24 11 44567-421-24 Magnesium Sulfate in Water 1 in 1 POUCH INJECTION 1 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44567-421 MAGNESIUM SULFATE IN WATER (MAGNESIUM SULFATE) INJECTION [WG CRITICAL CARE, LLC] 11 Current NDC, Legacy NDC, 2 package rows 20240203_752f55bb-c4ca-4545-94b3-3deea66888d4.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 44567-421-24 44567042124 24 POUCH in 1 CARTON (44567-421-24) / 1 BAG in 1 POUCH / 100 mL in 1 BAG 24 pouch 2018-01-09 0000-00-00 No No Current