FDA.reportPublic FDA data

magnesium sulfate

Product NDC
63323-106
11-digit product format
633230106
Labeler code
63323
Product ID
63323-106_48486022-130e-4a6a-87e7-db7c53eb5e75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MAGNESIUM SULFATE HEPTAHYDRATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA206485
Marketing category
ANDA
Marketing start
2016-03-15
Substance
MAGNESIUM SULFATE HEPTAHYDRATE
Active strength
40 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
magnesium sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM SULFATE HEPTAHYDRATE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSK47B8698T
Rxcui829734, 1658259, 1658262, 1658264, 1658265

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
63323-106-00magnesium sulfate100 mL in 1 BAGINJECTION, SOLUTION1006
63323-106-01magnesium sulfate24 in 1 CASEINJECTION, SOLUTION246
63323-106-02magnesium sulfate50 mL in 1 BAGINJECTION, SOLUTION506
63323-106-05magnesium sulfate24 in 1 CASEINJECTION, SOLUTION246
63323-106-10magnesium sulfate1000 mL in 1 BAGINJECTION, SOLUTION10006
63323-106-10magnesium sulfate24 in 1 CASEINJECTION, SOLUTION246
63323-106-15magnesium sulfate24 in 1 CASEINJECTION, SOLUTION246
63323-106-15magnesium sulfate500 mL in 1 BAGINJECTION, SOLUTION5006
63323-106-03magnesium sulfate50 mL in 1 BAGINJECTION, SOLUTION504
63323-106-26magnesium sulfate24 in 1 CASEINJECTION, SOLUTION244

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-106-00ML - Milliliter63323-1069ace8689-931a-4197-9319-b72bd2a37ae612020-08-06
63323-106-01ML - Milliliter63323-1067f8b40d2-995b-4c49-ade4-80b88379609e12016-07-19
63323-106-02ML - Milliliter63323-106b3bde1aa-065e-4b32-9b7a-bca6702d956e12020-08-06
63323-106-03ML - Milliliter63323-10630edc205-da2b-48e7-b0a9-987df29b33c612020-08-06
63323-106-05ML - Milliliter63323-106160cd784-d21d-453d-b23c-c3aa6833bc0c12016-07-19
63323-106-10ML - Milliliter63323-1066e3762be-c4ef-4162-8a4e-07b4fd046a0e12016-07-19
63323-106-15ML - Milliliter63323-10677c09967-5056-42c9-98c0-ad67545c2e8312016-07-19
63323-106-26ML - Milliliter63323-106e55caef4-abd3-4bdd-901b-26167f975e4212017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-106MAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC, 8 package rows20240427_fef9e18c-5210-4090-b564-4950ebe461c0.zip
63323-106MAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 2 package rows20240427_43d658b1-2b19-44be-a346-cac11fd600b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658259magnesium sulfate 2 GM in 50 ML InjectionPSNfef9e18c-5210-4090-b564-4950ebe461c06
1658264magnesium sulfate 20 GM in 500 ML InjectionPSNfef9e18c-5210-4090-b564-4950ebe461c06
1658262magnesium sulfate 4 GM in 100 ML InjectionPSNfef9e18c-5210-4090-b564-4950ebe461c06
829734magnesium sulfate 4 GM in 50 ML InjectionPSNfef9e18c-5210-4090-b564-4950ebe461c06
1658265magnesium sulfate 40 GM in 1000 ML InjectionPSNfef9e18c-5210-4090-b564-4950ebe461c06
1658262100 ML magnesium sulfate 40 MG/ML InjectionSCDfef9e18c-5210-4090-b564-4950ebe461c06
16582651000 ML magnesium sulfate 40 MG/ML InjectionSCDfef9e18c-5210-4090-b564-4950ebe461c06
165825950 ML magnesium sulfate 40 MG/ML InjectionSCDfef9e18c-5210-4090-b564-4950ebe461c06
82973450 ML magnesium sulfate 80 MG/ML InjectionSCDfef9e18c-5210-4090-b564-4950ebe461c06
1658264500 ML magnesium sulfate 40 MG/ML InjectionSCDfef9e18c-5210-4090-b564-4950ebe461c06
1658259magnesium sulfate 2 GM per 50 ML InjectionSYfef9e18c-5210-4090-b564-4950ebe461c06
1658264magnesium sulfate 20 GM per 500 ML InjectionSYfef9e18c-5210-4090-b564-4950ebe461c06
1658262magnesium sulfate 4 GM per 100 ML InjectionSYfef9e18c-5210-4090-b564-4950ebe461c06
829734magnesium sulfate 4 GM per 50 ML InjectionSYfef9e18c-5210-4090-b564-4950ebe461c06
1658265magnesium sulfate 40 GM per 1000 ML InjectionSYfef9e18c-5210-4090-b564-4950ebe461c06
1658259magnesium sulfate 2 GM in 50 ML InjectionPSN43d658b1-2b19-44be-a346-cac11fd600b34
1658264magnesium sulfate 20 GM in 500 ML InjectionPSN43d658b1-2b19-44be-a346-cac11fd600b34
1658262magnesium sulfate 4 GM in 100 ML InjectionPSN43d658b1-2b19-44be-a346-cac11fd600b34
1658265magnesium sulfate 40 GM in 1000 ML InjectionPSN43d658b1-2b19-44be-a346-cac11fd600b34
1658262100 ML magnesium sulfate 40 MG/ML InjectionSCD43d658b1-2b19-44be-a346-cac11fd600b34
16582651000 ML magnesium sulfate 40 MG/ML InjectionSCD43d658b1-2b19-44be-a346-cac11fd600b34
165825950 ML magnesium sulfate 40 MG/ML InjectionSCD43d658b1-2b19-44be-a346-cac11fd600b34
1658264500 ML magnesium sulfate 40 MG/ML InjectionSCD43d658b1-2b19-44be-a346-cac11fd600b34
1658259magnesium sulfate 2 GM per 50 ML InjectionSY43d658b1-2b19-44be-a346-cac11fd600b34
1658264magnesium sulfate 20 GM per 500 ML InjectionSY43d658b1-2b19-44be-a346-cac11fd600b34
1658262magnesium sulfate 4 GM per 100 ML InjectionSY43d658b1-2b19-44be-a346-cac11fd600b34
1658265magnesium sulfate 40 GM per 1000 ML InjectionSY43d658b1-2b19-44be-a346-cac11fd600b34
1658259magnesium sulfate 2 GM in 50 ML InjectionPSN9947731b-fb0f-0c68-e053-2a95a90a815e3
165825950 ML magnesium sulfate 40 MG/ML InjectionSCD9947731b-fb0f-0c68-e053-2a95a90a815e3
1658259magnesium sulfate 2 GM per 50 ML InjectionSY9947731b-fb0f-0c68-e053-2a95a90a815e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-106-0063323010600100 mL in 1 BAG100 mlHistorical
63323-106-016332301060124 BAG in 1 CASE (63323-106-01) / 100 mL in 1 BAG (63323-106-00) 24 bag2016-03-150000-00-00NoNoCurrent
63323-106-026332301060250 mL in 1 BAG50 mlHistorical
63323-106-036332301060350 mL in 1 BAG50 mlHistorical
63323-106-056332301060524 BAG in 1 CASE (63323-106-05) / 50 mL in 1 BAG (63323-106-02) 24 bag2016-03-150000-00-00NoNoCurrent
63323-106-106332301061024 BAG in 1 CASE (63323-106-10) / 1000 mL in 1 BAG24 bag2016-03-150000-00-00NoNoCurrent
63323-106-156332301061524 BAG in 1 CASE (63323-106-15) / 500 mL in 1 BAG24 bag2016-03-150000-00-00NoNoCurrent
63323-106-266332301062624 BAG in 1 CASE (63323-106-26) / 50 mL in 1 BAG (63323-106-03) 24 bag2016-03-150000-00-00NoNoCurrent