MAGNESIUM SULFATE

Product NDC
68083-397
11-digit product format
680830397
Labeler code
68083
Product ID
68083-397_4166c4fd-2951-4ab0-ab2a-6da9dd39927e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MAGNESIUM SULFATE HEPTAHYDRATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA213917
Marketing category
ANDA
Marketing start
2020-07-10
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
2026-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213917-001MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATE2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2020-07-10
A213917-002MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATE4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2020-07-10

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A213917-001AP
A213917-002AP

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAGNESIUM SULFATEMAGNESIUM SULFATE HEPTAHYDRATEGland Pharma Limiteda9e706ac-9c5f-4b14-b277-53dee195ffc62020-07-14Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNINGS FETAL HARM: Continuous administration of magnesium sulfate beyond 5 to 7 days to pregnant women can lead to hypocalcemia and bone abnormalities in the developing fetus. These bone abnormalities include skeletal demineralization and osteopenia. In addition, cases of neonatal fracture have been reported. The shortest duration of treatment that can lead to fetal harm is not known. Magnesium sulfate should be used during pregnancy only if clearly needed. If magnesium sulfate is given for treatment of preterm labor, the woman should be informed that the efficacy and safety of such use have not been established and that use of magnesium sulfate beyond 5 to 7 days may cause fetal abnormalities. Parenteral use in the presence of renal insufficiency may lead to magnesium intoxication.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

ADVERSE REACTIONS The adverse effects of parenterally administered magnesium usually are the result of magnesium intoxication. These include flushing, sweating, hypotension, depressed reflexes, flaccid paralysis, hypothermia, circulatory collapse, cardiac and central nervous system depression proceeding to respiratory paralysis. Hypocalcemia with signs of tetany secondary to magnesium sulfate therapy for eclampsia has been reported.

Additional Listing Data#

Finished product
Yes
Brand name base
MAGNESIUM SULFATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM SULFATE HEPTAHYDRATE4 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSK47B8698T
Rxcui1658259, 1658262

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-397-01MAGNESIUM SULFATE24 in 1 CASEINJECTION, SOLUTION244
68083-397-01MAGNESIUM SULFATE1 in 1 POUCHINJECTION, SOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-397MAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [GLAND PHARMA LIMITED]4Current NDC, Legacy NDC, 2 package rows20200715_a9e706ac-9c5f-4b14-b277-53dee195ffc6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658259magnesium sulfate 2 GM in 50 ML InjectionPSNa9e706ac-9c5f-4b14-b277-53dee195ffc64
1658262magnesium sulfate 4 GM in 100 ML InjectionPSNa9e706ac-9c5f-4b14-b277-53dee195ffc64
1658262100 ML magnesium sulfate 40 MG/ML InjectionSCDa9e706ac-9c5f-4b14-b277-53dee195ffc64
165825950 ML magnesium sulfate 40 MG/ML InjectionSCDa9e706ac-9c5f-4b14-b277-53dee195ffc64
1658259magnesium sulfate 2 GM per 50 ML InjectionSYa9e706ac-9c5f-4b14-b277-53dee195ffc64
1658262magnesium sulfate 4 GM per 100 ML InjectionSYa9e706ac-9c5f-4b14-b277-53dee195ffc64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68083-397-016808303970124 POUCH in 1 CASE (68083-397-01) / 1 BAG in 1 POUCH / 100 mL in 1 BAG24 pouch2020-07-100000-00-00NoNoCurrent