Home NDC 44567-423 Magnesium Sulfate in Water
Product NDC 44567-423
11-digit product format 445670423
Labeler code 44567
Product ID 44567-423_afe639dd-97a2-4cde-8ae0-916566d39137
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
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SK47B8698T Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 829734 Internal RxNorm lookup 1658259 Internal RxNorm lookup 1658262 Internal RxNorm lookup 1658264 Internal RxNorm lookup 1658265 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
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.
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