Home NDC 44567-423-10 Magnesium Sulfate in Water
Product NDC 44567-423
Requested package NDC 44567-423-10
11-digit product format 445670423
Labeler code 44567
Product ID 44567-423_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 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 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 1 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 2026-09-14 22:38:34 2026-08 A207350-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207350-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207350-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2017-12-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207350-004 MAGNESIUM SULFATE IN PLASTIC CONTAINER 20GM/500ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207350-005 MAGNESIUM SULFATE IN PLASTIC CONTAINER 40GM/1000ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207350-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207350-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207350-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2017-12-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207350-004 MAGNESIUM SULFATE IN PLASTIC CONTAINER 20GM/500ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207350-005 MAGNESIUM SULFATE IN PLASTIC CONTAINER 40GM/1000ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207350-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207350-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207350-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2017-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207350-004 MAGNESIUM SULFATE IN PLASTIC CONTAINER 20GM/500ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207350-005 MAGNESIUM SULFATE IN PLASTIC CONTAINER 40GM/1000ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207350-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207350-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207350-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2017-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207350-004 MAGNESIUM SULFATE IN PLASTIC CONTAINER 20GM/500ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207350-005 MAGNESIUM SULFATE IN PLASTIC CONTAINER 40GM/1000ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207350-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207350-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207350-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2017-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207350-004 MAGNESIUM SULFATE IN PLASTIC CONTAINER 20GM/500ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207350-005 MAGNESIUM SULFATE IN PLASTIC CONTAINER 40GM/1000ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207350-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207350-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207350-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2017-12-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207350-004 MAGNESIUM SULFATE IN PLASTIC CONTAINER 20GM/500ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207350-005 MAGNESIUM SULFATE IN PLASTIC CONTAINER 40GM/1000ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207350-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207350-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207350-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2017-12-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207350-004 MAGNESIUM SULFATE IN PLASTIC CONTAINER 20GM/500ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207350-005 MAGNESIUM SULFATE IN PLASTIC CONTAINER 40GM/1000ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207350-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207350-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207350-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2017-12-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207350-004 MAGNESIUM SULFATE IN PLASTIC CONTAINER 20GM/500ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207350-005 MAGNESIUM SULFATE IN PLASTIC CONTAINER 40GM/1000ML (40MG/ML) INJECTABLE / INJECTION AP 2017-12-06 03ed91905a0d…
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 40 g/1000mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 44567-423-10 Magnesium Sulfate in Water 1000 mL in 1 BAG INJECTION 1000 11 44567-423-10 Magnesium Sulfate in Water 10 in 1 CARTON INJECTION 10 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44567-423 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 44567-423-10 44567042310 10 BAG in 1 CARTON (44567-423-10) / 1000 mL in 1 BAG 10 bag 2018-01-09 0000-00-00 No No Current