Magnesium Sulfate Injection

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2015-05-21)
Oldest Current Product
1987-07-22
License(s)
NDA, ANDA, UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
INJECTION\MAGNESIUM SULFATE
FDAOB
INJECTION\INJECTION\MAGNESIUM SULFATE\rdfq
INTRAMUSCULAR, INTRAVENOUS\SOLUTION\MAGNESIUM SULFATE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\MAGNESIUM SULFATE HEPTAHYDRATE
INTRAMUSCULAR\INJECTION\MAGNESIUM SULFATE HEPTAHYDRATE
INTRAVENOUS\INJECTION, SOLUTION\MAGNESIUM SULFATE HEPTAHYDRATE
INTRAVENOUS\INJECTION, SOLUTION\MAGNESIUM SULFATE, UNSPECIFIED FORM
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\MAGNESIUM CATION
INTRAMUSCULAR\INJECTION\MAGNESIUM
INTRAVENOUS\INJECTION, SOLUTION\MAGNESIUM CATION

product(s) by strength(s)

100 ml magnesium sulfate 10 mg/ml injection

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004096727NDAHospira, Inc.1995-07-11MAGNESIUM SULFATE HEPTAHYDRATEINTRAVENOUSINJECTION, SOLUTIONNDA02048803ebeabb-8386-4af4-3086-bdf3c3fc4a5a

magnesium sulfate 20 mg/ml injection

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004096728NDAHospira, Inc.1995-07-11MAGNESIUM SULFATE HEPTAHYDRATEINTRAVENOUSINJECTION, SOLUTIONNDA02048803ebeabb-8386-4af4-3086-bdf3c3fc4a5a

magnesium sulfate 40 mg/ml injection

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1525330099UNAPPROVED DRUG OTHER MARKETING CATEGORYCantrell Drug Company2011-02-21MAGNESIUM SULFATE, UNSPECIFIED FORMINTRAVENOUSINJECTION, SOLUTION88f80e1e-d6e3-4789-abe1-f62db9ca366b

magnesium sulfate 500 mg/ml injection

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230064NDA, UNAPPROVED DRUG OTHER MARKETING CATEGORYApp Pharmaceuticals, Llc2000-08-08MAGNESIUM SULFATE HEPTAHYDRATEINTRAMUSCULARINJECTION, SOLUTIONNDA019316521e31cb-7a5c-47ae-a564-6ca069417e69, e921a46b-9a5b-4163-9c88-224247541f14, e9c10579-29f3-4889-8881-0626f63968d4, fc7e6658-b09e-49e4-b672-76072d772511

20 ml magnesium sulfate 500 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004092168ANDAHospira, Inc.1987-07-22MAGNESIUM SULFATE HEPTAHYDRATEINTRAMUSCULARINJECTION, SOLUTIONANDA202411e175d329-315f-4f3b-bb4c-06ad4e042967

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productspl
1525840168UNAPPROVED DRUG OTHER MARKETING CATEGORYGeneral Injecatables & Vaccines, Inc2010-09-01MAGNESIUM SULFATE HEPTAHYDRATEINTRAMUSCULARINJECTION0040921682a9a876a-37ee-45d3-9055-b6958f69d5bd
2551549394UNAPPROVED DRUG OTHER MARKETING CATEGORYCardinal Health2000-08-08MAGNESIUM SULFATE HEPTAHYDRATEINTRAMUSCULARINJECTION, SOLUTION6332300645d8e2eca-8a3b-42ef-9e41-cd5c18ad8f97

10 ml magnesium sulfate 500 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1398224025ANDAX-Gen Pharmaceuticals, Inc.2014-02-23MAGNESIUM SULFATE HEPTAHYDRATEINTRAMUSCULARINJECTION, SOLUTIONANDA2060392d705d6b-2fa4-4dce-9a1b-47ef21f011f1

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840754ANDAGeneral Injecatables & Vaccines, Inc2010-08-01MAGNESIUM SULFATE HEPTAHYDRATEINTRAMUSCULARINJECTION, SOLUTION004091754ANDA075151a945af86-e4d6-46ff-bb65-971df3bf8415

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840064NDAGeneral Injecatables & Vaccines, Inc2015-09-16MAGNESIUM SULFATE HEPTAHYDRATEINTRAMUSCULARINJECTION, SOLUTION633230064NDA01931667051167-d809-4a70-af77-de33f024bc89
2525840602UNAPPROVED DRUG OTHER MARKETING CATEGORYGeneral Injecatables & Vaccines, Inc2010-08-01MAGNESIUM SULFATE HEPTAHYDRATEINTRAMUSCULARINJECTION, SOLUTION0051726028f775557-e414-4119-89a8-c19334f5f116
3551549358NDACardinal Health2000-08-08MAGNESIUM SULFATE HEPTAHYDRATEINTRAMUSCULARINJECTION, SOLUTION633230064NDA0193166d5f80ca-3ac4-4919-b92e-730a97bdc253

50 ml magnesium sulfate 80 mg/ml injection

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004096730NDAHospira, Inc.1994-06-24MAGNESIUM SULFATE HEPTAHYDRATEINTRAVENOUSINJECTION, SOLUTIONNDA02030922ca78b4-f5a3-4144-cf89-5f633acf1e6d

application(s)

#idtitleapplicantapprovedapproved drugin other drug docs
1ANDA075151MAGNESIUM SULFATEHOSPIRA INC2000-04-25ANDA075151_001Magnesium Sulfate Prefilled Syringe
2ANDA202411MAGNESIUM SULFATEHOSPIRA INC2015-05-14ANDA202411_001Magnesium Sulfate Prefilled Syringe
3ANDA206039MAGNESIUM SULFATEEXELA PHARMA SCIENCES LLC2014-12-18ANDA206039_001Magnesium Sulfate Prefilled Syringe
4NDA019316MAGNESIUM SULFATEFRESENIUS KABI USA LLC1986-09-08NDA019316_001, NDA019316_002Magnesium Sulfate Prefilled Syringe
5NDA020309MAGNESIUM SULFATE IN PLASTIC CONTAINERHOSPIRA INC1994-06-24NDA020309_001, NDA020309_002, NDA020309_003, NDA020309_004, NDA020309_005
6NDA020488MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINERHOSPIRA INC1995-07-11NDA020488_001, NDA020488_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA075151_001RXMAGNESIUM SULFATE (5GM/10ML)SOLUTIONTrueAP2000-04-25MAGNESIUM SULFATE
2ANDA202411_001RXMAGNESIUM SULFATE (10GM/20ML)SOLUTIONFalse2015-05-14MAGNESIUM SULFATE
3ANDA206039_001RXMAGNESIUM SULFATE (5GM/10ML)SOLUTIONFalseAP2014-12-18MAGNESIUM SULFATE
4NDA019316_001RXMAGNESIUM SULFATE (5GM/10ML)SOLUTIONTrueAP1986-09-08MAGNESIUM SULFATE
5NDA019316_002RXMAGNESIUM SULFATE (1GM/2ML)SOLUTIONTrue1986-09-08MAGNESIUM SULFATE
6NDA020309_001RXMAGNESIUM SULFATE (4GM/100ML)INJECTIONTrue1994-06-24MAGNESIUM SULFATE IN PLASTIC CONTAINER
7NDA020309_002RXMAGNESIUM SULFATE (4GM/50ML)INJECTIONTrue1994-06-24MAGNESIUM SULFATE IN PLASTIC CONTAINER
8NDA020309_003RXMAGNESIUM SULFATE (2GM/50ML)INJECTIONFalse2007-01-26MAGNESIUM SULFATE IN PLASTIC CONTAINER
9NDA020309_004RXMAGNESIUM SULFATE (20GM/500ML)INJECTIONFalse1995-01-18MAGNESIUM SULFATE IN PLASTIC CONTAINER
10NDA020309_005RXMAGNESIUM SULFATE (40GM/1000ML(40MG/ML))INJECTIONFalse1995-01-18MAGNESIUM SULFATE IN PLASTIC CONTAINER
11NDA020488_001RXMAGNESIUM SULFATE (1GM/100ML)INJECTIONTrue1995-07-11MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
12NDA020488_002RXMAGNESIUM SULFATE (2GM/100ML)INJECTIONTrue1995-07-11MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
103ebeabb-8386-4af4-3086-bdf3c3fc4a5a (view SPL)MAGNESIUM SULFATEIN 5% DEXTROSE INJECTION, USPprescriptionHuman PrescriptionHospira, Inc.2013-05-2914004096727, 004096728
222ca78b4-f5a3-4144-cf89-5f633acf1e6d (view SPL)MAGNESIUM SULFATEIN WATER FOR INJECTIONprescriptionHuman PrescriptionHospira, Inc.2013-05-2915004096730, 004096729
32a9a876a-37ee-45d3-9055-b6958f69d5bd (view SPL)50% Magnesium Sulfate 4 mEq/mL Injection, USP 20 mL Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2010-09-092525840168
42d705d6b-2fa4-4dce-9a1b-47ef21f011f1 (view SPL)Magnesium Sulfate Injection USPprescriptionHuman PrescriptionX-Gen Pharmaceuticals, Inc.2014-12-018398224025
5521e31cb-7a5c-47ae-a564-6ca069417e69 (view SPL)Magnesium Sulfate Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-07-151633230064
65d8e2eca-8a3b-42ef-9e41-cd5c18ad8f97 (view SPL)Magnesium Sulfate Injection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2015-09-012551549394
767051167-d809-4a70-af77-de33f024bc89 (view SPL)Magnesium SulfateprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2015-09-151525840064
86d5f80ca-3ac4-4919-b92e-730a97bdc253 (view SPL)Magnesium Sulfate Injection USPprescriptionHuman PrescriptionCardinal HealthREPACK2015-07-015551549358
988f80e1e-d6e3-4789-abe1-f62db9ca366b (view SPL)Magnesium Sulfate 20 g Added to Lactated Ringer's 500 mL BagprescriptionHuman PrescriptionCantrell Drug Company2012-11-212525330099
108f775557-e414-4119-89a8-c19334f5f116 (view SPL)50% Magnesium Sulfate 0.5 gm/mL Injection, USP 2 mL Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Increlabel2010-08-241525840602
11a945af86-e4d6-46ff-bb65-971df3bf8415 (view SPL)50% Magnesium Sulfate 5 gm/mL Injection, USP 10 mL PreFilled SyringeprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2011-06-062525840754
12e175d329-315f-4f3b-bb4c-06ad4e042967 (view SPL)Magnesium SulfateRx only Injection, USP 50% Fliptop VialprescriptionHuman PrescriptionHospira, Inc.2015-05-213004092168
13e921a46b-9a5b-4163-9c88-224247541f14 (view SPL)Magnesium Sulfate Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-04-031633230064
14e9c10579-29f3-4889-8881-0626f63968d4 (view SPL)Magnesium Sulfate Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2013-05-142633230064
15fc7e6658-b09e-49e4-b672-76072d772511 (view SPL)Magnesium Sulfate Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2013-11-072633230064

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII