FDA.reportPublic FDA data

Magnesium Sulfate

Product NDC
63323-064
11-digit product format
633230064
Labeler code
63323
Product ID
63323-064_ac877c06-691b-4bc1-830b-8f4403d526d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MAGNESIUM SULFATE HEPTAHYDRATE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
NDA019316
Marketing category
NDA
Marketing start
2000-08-08
Substance
MAGNESIUM SULFATE HEPTAHYDRATE
Active strength
500 mg/mL
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

Additional Listing Data#

Finished product
Yes
Brand name base
Magnesium Sulfate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM SULFATE HEPTAHYDRATE500 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSK47B8698T
Rxcui1658221, 1658244

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
63323-064-01Magnesium Sulfate2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION29
63323-064-02Magnesium Sulfate2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION29
63323-064-02Magnesium Sulfate25 in 1 TRAYINJECTION, SOLUTION259
63323-064-03Magnesium Sulfate25 in 1 CARTONINJECTION, SOLUTION259
63323-064-04Magnesium Sulfate10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION109
63323-064-10Magnesium Sulfate10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION109
63323-064-10Magnesium Sulfate25 in 1 TRAYINJECTION, SOLUTION259
63323-064-11Magnesium Sulfate25 in 1 TRAYINJECTION, SOLUTION259
63323-064-21Magnesium Sulfate2 mL in 1 VIAL, GLASSINJECTION, SOLUTION25
63323-064-23Magnesium Sulfate25 in 1 TRAYINJECTION, SOLUTION255
63323-064-26Magnesium Sulfate25 in 1 TRAYINJECTION, SOLUTION255
63323-064-26Magnesium Sulfate2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION25
63323-064-41Magnesium Sulfate2 mL in 1 VIAL, GLASSINJECTION, SOLUTION25
63323-064-43Magnesium Sulfate25 in 1 TRAYINJECTION, SOLUTION255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-064-01ML - Milliliter63323-064388deca7-0986-493c-ba69-084125e6204812018-03-08
63323-064-02ML - Milliliter63323-0646dfaff0d-fabf-40b1-a08b-b10f9b25f14312013-02-13
63323-064-03ML - Milliliter63323-064fa799104-7303-46b1-bb57-f50d6175ab1712018-02-20
63323-064-04ML - Milliliter63323-06404083129-98c0-4e71-a18d-d60c5966cc6312018-03-08
63323-064-09ML - Milliliter63323-0641fac92e9-edc3-42a5-8e60-c72a22d52ecc12014-09-03
63323-064-10ML - Milliliter63323-064faa84df3-78d5-4ac4-baa3-b8b36e7ef91312013-02-13
63323-064-11ML - Milliliter63323-064b5c53d6b-a0ed-474c-b06c-b5c8078038a812018-02-20
63323-064-20ML - Milliliter63323-0642a548f11-c480-46f6-bc4a-75d82a8f2a6c12013-02-13
63323-064-21ML - Milliliter63323-064ee03d12c-5823-45bd-9cc4-409282daf8f012021-04-08
63323-064-23ML - Milliliter63323-0643251c497-6019-4164-b143-97e78cd4191412018-12-13
63323-064-26ML - Milliliter63323-064ebdb991c-8220-4ef8-a732-792c9725857a12016-06-14
63323-064-29ML - Milliliter63323-064580772df-ab40-477d-a095-fcb26472a28912014-09-03
63323-064-41ML - Milliliter63323-064fa24f111-1557-47f2-aafc-39104aef158412018-07-03
63323-064-43ML - Milliliter63323-064d0632775-134d-4d96-affb-36ab0520820112018-07-03
63323-064-50ML - Milliliter63323-064e16e4422-4cc6-4c4b-86e5-c58f498b363112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MAGNESIUM SULFATE HEPTAHYDRATEACTIVE INGREDIENTSK47B8698TMAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838MAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFMAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
MAGNESIUM SULFATE HEPTAHYDRATEACTIVE INGREDIENTSK47B8698TMAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838MAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFMAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-064MAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]7Current NDC, Legacy NDC, 8 package rows20231109_e9c10579-29f3-4889-8881-0626f63968d4.zip
63323-064MAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 2 package rows20210320_e921a46b-9a5b-4163-9c88-224247541f14.zip
63323-064MAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 4 package rows20210320_6a5d362b-7aa7-40d3-898d-09407cce0713.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658221magnesium sulfate 1 GM in 2 ML InjectionPSNe9c10579-29f3-4889-8881-0626f63968d49
1658244magnesium sulfate 5 GM in 10 ML InjectionPSNe9c10579-29f3-4889-8881-0626f63968d49
165824410 ML magnesium sulfate 500 MG/ML InjectionSCDe9c10579-29f3-4889-8881-0626f63968d49
16582212 ML magnesium sulfate 500 MG/ML InjectionSCDe9c10579-29f3-4889-8881-0626f63968d49
1658221magnesium sulfate 1 GM per 2 ML InjectionSYe9c10579-29f3-4889-8881-0626f63968d49
1658244magnesium sulfate 5 GM per 10 ML InjectionSYe9c10579-29f3-4889-8881-0626f63968d49
1658221magnesium sulfate 1 GM in 2 ML InjectionPSN6a5d362b-7aa7-40d3-898d-09407cce07135
1658221magnesium sulfate 1 GM in 2 ML InjectionPSNe921a46b-9a5b-4163-9c88-224247541f145
1658221magnesium sulfate 1 GM in 2 ML InjectionPSN5176ed24-015e-43fe-9eb4-85098debf5f15
1658244magnesium sulfate 5 GM in 10 ML InjectionPSN6a5d362b-7aa7-40d3-898d-09407cce07135
1658244magnesium sulfate 5 GM in 10 ML InjectionPSNe921a46b-9a5b-4163-9c88-224247541f145
165824410 ML magnesium sulfate 500 MG/ML InjectionSCD6a5d362b-7aa7-40d3-898d-09407cce07135
165824410 ML magnesium sulfate 500 MG/ML InjectionSCDe921a46b-9a5b-4163-9c88-224247541f145
16582212 ML magnesium sulfate 500 MG/ML InjectionSCD5176ed24-015e-43fe-9eb4-85098debf5f15
16582212 ML magnesium sulfate 500 MG/ML InjectionSCD6a5d362b-7aa7-40d3-898d-09407cce07135
16582212 ML magnesium sulfate 500 MG/ML InjectionSCDe921a46b-9a5b-4163-9c88-224247541f145
1658221magnesium sulfate 1 GM per 2 ML InjectionSY6a5d362b-7aa7-40d3-898d-09407cce07135
1658221magnesium sulfate 1 GM per 2 ML InjectionSY5176ed24-015e-43fe-9eb4-85098debf5f15
1658221magnesium sulfate 1 GM per 2 ML InjectionSYe921a46b-9a5b-4163-9c88-224247541f145
1658244magnesium sulfate 5 GM per 10 ML InjectionSY6a5d362b-7aa7-40d3-898d-09407cce07135
1658244magnesium sulfate 5 GM per 10 ML InjectionSYe921a46b-9a5b-4163-9c88-224247541f145
1658221magnesium sulfate 1 GM in 2 ML InjectionPSN945419b8-6184-f4f3-e053-2a95a90a62363
1658244magnesium sulfate 5 GM in 10 ML InjectionPSN9970acda-3a9a-7e5d-e053-2995a90a25d33
165824410 ML magnesium sulfate 500 MG/ML InjectionSCD9970acda-3a9a-7e5d-e053-2995a90a25d33
16582212 ML magnesium sulfate 500 MG/ML InjectionSCD945419b8-6184-f4f3-e053-2a95a90a62363
1658221magnesium sulfate 1 GM per 2 ML InjectionSY945419b8-6184-f4f3-e053-2a95a90a62363
1658244magnesium sulfate 5 GM per 10 ML InjectionSY9970acda-3a9a-7e5d-e053-2995a90a25d33
1658244magnesium sulfate 5 GM in 10 ML InjectionPSNb6352fbd-d3ee-2d3a-e053-2a95a90a747d1
1658244magnesium sulfate 5 GM in 10 ML InjectionPSN8c6b8b3d-9c04-4ed7-86b8-89065b6bf50d1
1658244magnesium sulfate 5 GM in 10 ML InjectionPSN3f003556-d675-1cf9-e063-6294a90a2cc41
1658244magnesium sulfate 5 GM in 10 ML InjectionPSN386d55c9-aeac-5597-e063-6294a90a0afe1
165824410 ML magnesium sulfate 500 MG/ML InjectionSCDb6352fbd-d3ee-2d3a-e053-2a95a90a747d1
165824410 ML magnesium sulfate 500 MG/ML InjectionSCD8c6b8b3d-9c04-4ed7-86b8-89065b6bf50d1
165824410 ML magnesium sulfate 500 MG/ML InjectionSCD3f003556-d675-1cf9-e063-6294a90a2cc41
165824410 ML magnesium sulfate 500 MG/ML InjectionSCD386d55c9-aeac-5597-e063-6294a90a0afe1
1658244magnesium sulfate 5 GM per 10 ML InjectionSYb6352fbd-d3ee-2d3a-e053-2a95a90a747d1
1658244magnesium sulfate 5 GM per 10 ML InjectionSY386d55c9-aeac-5597-e063-6294a90a0afe1
1658244magnesium sulfate 5 GM per 10 ML InjectionSY8c6b8b3d-9c04-4ed7-86b8-89065b6bf50d1
1658244magnesium sulfate 5 GM per 10 ML InjectionSY3f003556-d675-1cf9-e063-6294a90a2cc41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-064-01633230064012 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
63323-064-02633230064022 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
63323-064-036332300640325 VIAL, SINGLE-DOSE in 1 CARTON (63323-064-03) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-064-01) 2000-08-080000-00-00NoNoCurrent
63323-064-046332300640410 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
63323-064-106332300641010 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
63323-064-116332300641125 VIAL, SINGLE-DOSE in 1 TRAY (63323-064-11) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-064-04) 2000-08-080000-00-00NoNoCurrent
63323-064-21633230064212 mL in 1 VIAL, GLASS2 mlHistorical
63323-064-236332300642325 VIAL, GLASS in 1 TRAY (63323-064-23) / 2 mL in 1 VIAL, GLASS (63323-064-21) 2000-08-080000-00-00NoNoCurrent
63323-064-266332300642625 in 1 TRAYHistorical
63323-064-41633230064412 mL in 1 VIAL, GLASS2 mlHistorical
63323-064-436332300644325 VIAL, GLASS in 1 TRAY (63323-064-43) / 2 mL in 1 VIAL, GLASS (63323-064-41) 2000-08-080000-00-00NoNoCurrent