FDA.reportPublic FDA data

Magnesium Sulfate

Product NDC
31722-394
11-digit product format
317220394
Labeler code
31722
Product ID
31722-394_36bf495e-3966-8317-e063-6294a90a055f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Magnesium sulfate heptahydrate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA219777
Marketing category
ANDA
Marketing start
2025-05-28
Substance
MAGNESIUM SULFATE HEPTAHYDRATE
Active strength
500 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 HEPTAHYDRATE500 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSK47B8698T
Rxcui1658221, 1658236, 1658244, 1658245

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
31722-394-10Magnesium Sulfate10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION101
31722-394-20Magnesium Sulfate20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION201
31722-394-31Magnesium Sulfate2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION21
31722-394-32Magnesium Sulfate25 in 1 CARTONINJECTION, SOLUTION251
31722-394-33Magnesium Sulfate25 in 1 CARTONINJECTION, SOLUTION251
31722-394-34Magnesium Sulfate25 in 1 CARTONINJECTION, SOLUTION251
31722-394-35Magnesium Sulfate25 in 1 CARTONINJECTION, SOLUTION251
31722-394-50Magnesium Sulfate50 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-394-10ML - Milliliter31722-394cb446454-8b58-46fa-8ee4-eebdf561700112025-09-12
31722-394-20ML - Milliliter31722-3940f68b233-74c3-49f9-9f2c-21e838948c6e12025-09-12
31722-394-31ML - Milliliter31722-394e557c4d9-2b8c-4ec8-9989-3c7e880de86d12025-09-12
31722-394-32ML - Milliliter31722-39493100f80-ed96-414d-b1d3-efae7d817b2b12025-09-12
31722-394-33ML - Milliliter31722-394fcdb703c-cd7f-4083-85c5-86365166ffd312025-09-12
31722-394-34ML - Milliliter31722-394362d353d-a23e-485c-9103-dbd48d488ffc12025-09-12
31722-394-35ML - Milliliter31722-3946b4fe1aa-3767-4e3f-9e2f-cd511868ba7212025-09-12
31722-394-50ML - Milliliter31722-394a669aa36-60a2-4a0b-8437-b13067554ee112025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658221magnesium sulfate 1 GM in 2 ML InjectionPSN647ca293-9e68-4773-947a-0fb064aa6fd11
1658236magnesium sulfate 10 GM in 20 ML InjectionPSN647ca293-9e68-4773-947a-0fb064aa6fd11
1658245magnesium sulfate 25 GM in 50 ML InjectionPSN647ca293-9e68-4773-947a-0fb064aa6fd11
1658244magnesium sulfate 5 GM in 10 ML InjectionPSN647ca293-9e68-4773-947a-0fb064aa6fd11
165824410 ML magnesium sulfate 500 MG/ML InjectionSCD647ca293-9e68-4773-947a-0fb064aa6fd11
16582212 ML magnesium sulfate 500 MG/ML InjectionSCD647ca293-9e68-4773-947a-0fb064aa6fd11
165823620 ML magnesium sulfate 500 MG/ML InjectionSCD647ca293-9e68-4773-947a-0fb064aa6fd11
165824550 ML magnesium sulfate 500 MG/ML InjectionSCD647ca293-9e68-4773-947a-0fb064aa6fd11
1658221magnesium sulfate 1 GM per 2 ML InjectionSY647ca293-9e68-4773-947a-0fb064aa6fd11
1658236magnesium sulfate 10 GM per 20 ML InjectionSY647ca293-9e68-4773-947a-0fb064aa6fd11
1658245magnesium sulfate 25 GM per 50 ML InjectionSY647ca293-9e68-4773-947a-0fb064aa6fd11
1658244magnesium sulfate 5 GM per 10 ML InjectionSY647ca293-9e68-4773-947a-0fb064aa6fd11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-394-103172203941010 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
31722-394-203172203942020 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
31722-394-31317220394312 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
31722-394-323172203943225 VIAL, SINGLE-DOSE in 1 CARTON (31722-394-32) / 2 mL in 1 VIAL, SINGLE-DOSE (31722-394-31) 2025-05-28NoNoHistorical
31722-394-333172203943325 VIAL, SINGLE-DOSE in 1 CARTON (31722-394-33) / 10 mL in 1 VIAL, SINGLE-DOSE (31722-394-10) 2025-05-28NoNoHistorical
31722-394-343172203943425 VIAL, SINGLE-DOSE in 1 CARTON (31722-394-34) / 20 mL in 1 VIAL, SINGLE-DOSE (31722-394-20) 2025-05-28NoNoHistorical
31722-394-353172203943525 VIAL, SINGLE-DOSE in 1 CARTON (31722-394-35) / 50 mL in 1 VIAL, SINGLE-DOSE (31722-394-50) 2025-05-28NoNoHistorical
31722-394-503172203945050 mL in 1 VIAL, SINGLE-DOSE50 mlHistorical