Magnesium Sulfate in Dextrose

Product NDC
0264-4400
11-digit product format
002644400
Labeler code
0264
Product ID
0264-4400_27f278a7-1ccc-4f74-99bd-2e9c806d4663
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
magnesium sulfate heptahydrate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
B. Braun Medical Inc.
Application
ANDA207966
Marketing category
ANDA
Marketing start
2020-10-27
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Magnesium Sulfate in Dextrose
Listing expiration
2026-12-31

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
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
0264-4400-54Magnesium Sulfate in Dextrose24 in 1 CASEINJECTION, SOLUTION248
0264-4400-54Magnesium Sulfate in Dextrose100 mL in 1 CONTAINERINJECTION, SOLUTION1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-4400-54ML - Milliliter0264-4400336cb569-e480-42b5-ad46-6c571e522b5c12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0264-4400MAGNESIUM SULFATE IN DEXTROSE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]7Current NDC, Legacy NDC, 2 package rows20210408_4876dcd9-5e8f-47ed-af4f-6a4009ccffd1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
829757magnesium sulfate 1 GM in 100 ML InjectionPSN4876dcd9-5e8f-47ed-af4f-6a4009ccffd18
829757100 ML magnesium sulfate 10 MG/ML InjectionSCD4876dcd9-5e8f-47ed-af4f-6a4009ccffd18
829757magnesium sulfate 1 GM per 100 ML InjectionSY4876dcd9-5e8f-47ed-af4f-6a4009ccffd18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0264-4400-540026444005424 CONTAINER in 1 CASE (0264-4400-54) / 100 mL in 1 CONTAINER24 container2020-10-270000-00-00NoNoCurrent