Magnesium Sulfate

Product NDC
25021-612
11-digit product format
250210612
Labeler code
25021
Product ID
25021-612_f91b940b-e459-46c8-886a-c1da0265da54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Magnesium Sulfate Heptahydrate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA213917
Marketing category
ANDA
Marketing start
2021-02-15
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
Rxcui1658259, 1658262

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
25021-612-81Magnesium Sulfate50 mL in 1 BAGINJECTION, SOLUTION501
25021-612-81Magnesium Sulfate10 in 1 CARTONINJECTION, SOLUTION101
25021-612-82Magnesium Sulfate10 in 1 CARTONINJECTION, SOLUTION101
25021-612-82Magnesium Sulfate100 mL in 1 BAGINJECTION, SOLUTION1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-612-81ML - Milliliter25021-612d0b6eb28-d718-4f07-8788-1e3bd80128ef12021-05-05
25021-612-82ML - Milliliter25021-61281de6140-fa14-4125-babb-fd21bcbe16a412021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-612MAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, Legacy NDC, 4 package rows20210215_a607796c-6676-4d0a-8108-8708fe6769ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658259magnesium sulfate 2 GM in 50 ML InjectionPSNa607796c-6676-4d0a-8108-8708fe6769ed1
1658262magnesium sulfate 4 GM in 100 ML InjectionPSNa607796c-6676-4d0a-8108-8708fe6769ed1
1658262100 ML magnesium sulfate 40 MG/ML InjectionSCDa607796c-6676-4d0a-8108-8708fe6769ed1
165825950 ML magnesium sulfate 40 MG/ML InjectionSCDa607796c-6676-4d0a-8108-8708fe6769ed1
1658259magnesium sulfate 2 GM per 50 ML InjectionSYa607796c-6676-4d0a-8108-8708fe6769ed1
1658262magnesium sulfate 4 GM per 100 ML InjectionSYa607796c-6676-4d0a-8108-8708fe6769ed1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-612-812502106128110 BAG in 1 CARTON (25021-612-81) / 50 mL in 1 BAG10 bag2021-02-150000-00-00NoNoCurrent
25021-612-822502106128210 BAG in 1 CARTON (25021-612-82) / 100 mL in 1 BAG10 bag2021-02-150000-00-00NoNoCurrent