FDA.reportPublic FDA data

Magnesium Sulfate in Water

Product NDC
0409-2050
11-digit product format
004092050
Labeler code
0409
Product ID
0409-2050_e435d27c-001a-4a01-8be4-76f18e577db6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MAGNESIUM SULFATE IN WATER
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA020309
Marketing category
NDA
Marketing start
2022-11-14
Substance
MAGNESIUM SULFATE HEPTAHYDRATE
Active strength
20 g/500mL
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 in Water
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM SULFATE HEPTAHYDRATE20 g/500mL

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
0409-2050-01Magnesium Sulfate in Water500 mL in 1 BAGINJECTION, SOLUTION50030
0409-2050-20Magnesium Sulfate in Water1 in 1 POUCHINJECTION, SOLUTION130
0409-2050-20Magnesium Sulfate in Water20 in 1 CASEINJECTION, SOLUTION2030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-2050-01ML - Milliliter0409-205023647b6b-58d0-435f-a92a-09977bc1b3ea12022-12-07
0409-2050-20ML - Milliliter0409-20504e1e8e90-a8d0-472a-9ead-faf7612fdc8012022-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MAGNESIUM SULFATE HEPTAHYDRATEACTIVE INGREDIENTSK47B8698TMAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]15
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838MAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]15
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]15
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFMAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]15
WATERINACTIVE INGREDIENT059QF0KO0RMAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-2050MAGNESIUM SULFATE IN WATER INJECTION, SOLUTION [HOSPIRA, INC.]27Current NDC, Legacy NDC, 3 package rows20241027_22ca78b4-f5a3-4144-cf89-5f633acf1e6d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658259magnesium sulfate 2 GM in 50 ML InjectionPSN22ca78b4-f5a3-4144-cf89-5f633acf1e6d30
1658264magnesium sulfate 20 GM in 500 ML InjectionPSN22ca78b4-f5a3-4144-cf89-5f633acf1e6d30
1658262magnesium sulfate 4 GM in 100 ML InjectionPSN22ca78b4-f5a3-4144-cf89-5f633acf1e6d30
829734magnesium sulfate 4 GM in 50 ML InjectionPSN22ca78b4-f5a3-4144-cf89-5f633acf1e6d30
1658265magnesium sulfate 40 GM in 1000 ML InjectionPSN22ca78b4-f5a3-4144-cf89-5f633acf1e6d30
1658262100 ML magnesium sulfate 40 MG/ML InjectionSCD22ca78b4-f5a3-4144-cf89-5f633acf1e6d30
16582651000 ML magnesium sulfate 40 MG/ML InjectionSCD22ca78b4-f5a3-4144-cf89-5f633acf1e6d30
165825950 ML magnesium sulfate 40 MG/ML InjectionSCD22ca78b4-f5a3-4144-cf89-5f633acf1e6d30
82973450 ML magnesium sulfate 80 MG/ML InjectionSCD22ca78b4-f5a3-4144-cf89-5f633acf1e6d30
1658264500 ML magnesium sulfate 40 MG/ML InjectionSCD22ca78b4-f5a3-4144-cf89-5f633acf1e6d30
1658259magnesium sulfate 2 GM per 50 ML InjectionSY22ca78b4-f5a3-4144-cf89-5f633acf1e6d30
1658264magnesium sulfate 20 GM per 500 ML InjectionSY22ca78b4-f5a3-4144-cf89-5f633acf1e6d30
1658262magnesium sulfate 4 GM per 100 ML InjectionSY22ca78b4-f5a3-4144-cf89-5f633acf1e6d30
829734magnesium sulfate 4 GM per 50 ML InjectionSY22ca78b4-f5a3-4144-cf89-5f633acf1e6d30
1658265magnesium sulfate 40 GM per 1000 ML InjectionSY22ca78b4-f5a3-4144-cf89-5f633acf1e6d30

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-2050-0100409205001500 mL in 1 BAG500 mlHistorical
0409-2050-200040920502020 POUCH in 1 CASE (0409-2050-20) / 1 BAG in 1 POUCH / 500 mL in 1 BAG (0409-2050-01) 20 pouch2022-11-140000-00-00NoNoCurrent