FDA.reportPublic FDA data

Magnesium Sulfate in Dextrose

Product NDC
0409-6727
11-digit product format
004096727
Labeler code
0409
Product ID
0409-6727_ba12f8c6-c313-4649-9ce8-100a8abb3ba6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Magnesium Sulfate in Dextrose
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA020488
Marketing category
NDA
Marketing start
2005-09-27
Substance
MAGNESIUM SULFATE HEPTAHYDRATE
Active strength
10 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 in Dextrose
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM SULFATE HEPTAHYDRATE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSK47B8698T
Rxcui829757

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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
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
0409-6727-11Magnesium Sulfate in Dextrose100 mL in 1 BAGINJECTION, SOLUTION10032
0409-6727-23Magnesium Sulfate in Dextrose24 in 1 CASEINJECTION, SOLUTION2432
0409-6727-23Magnesium Sulfate in Dextrose1 in 1 POUCHINJECTION, SOLUTION132
0409-6727-50Magnesium Sulfate in Dextrose1 in 1 POUCHINJECTION, SOLUTION132
0409-6727-50Magnesium Sulfate in Dextrose50 in 1 CASEINJECTION, SOLUTION5032
0409-6727-55Magnesium Sulfate in Dextrose100 mL in 1 BAGINJECTION, SOLUTION10032

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-6727-11ML - Milliliter0409-6727f71d0be6-f5d6-4f7f-a4bb-aa137765368612020-07-13
0409-6727-23ML - Milliliter0409-6727c287a3fc-94da-41b4-8c7f-7c7937066bd412012-07-24
0409-6727-50ML - Milliliter0409-67273098cc65-148f-48b7-8e16-83814115fd5612023-01-09
0409-6727-55ML - Milliliter0409-6727e4a6a37e-65a4-414d-80d0-8f6557a2749b12023-01-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MAGNESIUM SULFATE HEPTAHYDRATEACTIVE INGREDIENTSK47B8698TMAGNESIUM SULFATE IN DEXTROSE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]14
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838MAGNESIUM SULFATE IN DEXTROSE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]14
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GMAGNESIUM SULFATE IN DEXTROSE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]14
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMAGNESIUM SULFATE IN DEXTROSE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]14
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFMAGNESIUM SULFATE IN DEXTROSE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]14
WATERINACTIVE INGREDIENT059QF0KO0RMAGNESIUM SULFATE IN DEXTROSE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-6727MAGNESIUM SULFATE IN DEXTROSE INJECTION, SOLUTION [HOSPIRA, INC.]28Current NDC, Legacy NDC, 6 package rows20241018_03ebeabb-8386-4af4-3086-bdf3c3fc4a5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
829757magnesium sulfate 1 GM in 100 ML InjectionPSN03ebeabb-8386-4af4-3086-bdf3c3fc4a5a32
829757100 ML magnesium sulfate 10 MG/ML InjectionSCD03ebeabb-8386-4af4-3086-bdf3c3fc4a5a32
829757magnesium sulfate 1 GM per 100 ML InjectionSY03ebeabb-8386-4af4-3086-bdf3c3fc4a5a32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-6727-1100409672711100 mL in 1 BAG100 mlHistorical
0409-6727-230040967272324 POUCH in 1 CASE (0409-6727-23) / 1 BAG in 1 POUCH / 100 mL in 1 BAG (0409-6727-11) 24 pouch2005-09-270000-00-00NoNoCurrent
0409-6727-500040967275050 POUCH in 1 CASE (0409-6727-50) > 1 BAG in 1 POUCH > 100 mL in 1 BAG (0409-6727-55) 50 pouch2022-12-270000-00-00NoNoCurrent
0409-6727-5500409672755100 mL in 1 BAG100 mlHistorical