FDA.reportPublic FDA data

Magnesium Sulfate in Water

Product NDC
0409-6729
11-digit product format
004096729
Labeler code
0409
Product ID
0409-6729_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
2005-08-22
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
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 HEPTAHYDRATE40 mg/mL

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
0409-6729-03Magnesium Sulfate in Water24 in 1 CASEINJECTION, SOLUTION2430
0409-6729-03Magnesium Sulfate in Water1 in 1 POUCHINJECTION, SOLUTION130
0409-6729-09Magnesium Sulfate in Water1 in 1 POUCHINJECTION, SOLUTION130
0409-6729-09Magnesium Sulfate in Water12 in 1 CASEINJECTION, SOLUTION1230
0409-6729-11Magnesium Sulfate in Water50 mL in 1 BAGINJECTION, SOLUTION5030
0409-6729-21Magnesium Sulfate in Water500 mL in 1 BAGINJECTION, SOLUTION50030
0409-6729-23Magnesium Sulfate in Water1 in 1 POUCHINJECTION, SOLUTION130
0409-6729-23Magnesium Sulfate in Water24 in 1 CASEINJECTION, SOLUTION2430
0409-6729-24Magnesium Sulfate in Water24 in 1 CASEINJECTION, SOLUTION2430
0409-6729-24Magnesium Sulfate in Water1 in 1 POUCHINJECTION, SOLUTION130
0409-6729-31Magnesium Sulfate in Water1000 mL in 1 BAGINJECTION, SOLUTION100030
0409-6729-41Magnesium Sulfate in Water100 mL in 1 BAGINJECTION, SOLUTION10030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-6729-03ML - Milliliter0409-6729ebf78096-a59f-4c5a-b1a7-6e2d09130d3a12012-07-24
0409-6729-09ML - Milliliter0409-67292f165523-b933-4e4b-9e85-78e344bc121e12012-07-24
0409-6729-11ML - Milliliter0409-6729fddaa8c0-e7c1-49e8-8cd3-23436d1173a812020-07-13
0409-6729-21ML - Milliliter0409-67293ed0e796-8192-41f9-b96d-456da4fb4efa12020-07-13
0409-6729-23ML - Milliliter0409-6729dae0ee8d-c5bc-4984-b3e0-89cd46a4b94e12012-07-24
0409-6729-24ML - Milliliter0409-6729e362d5bc-ee6c-4a08-8ee1-8c59627c66d512012-07-24
0409-6729-31ML - Milliliter0409-67294ac824d5-a3ea-45e4-8f9d-d8464e9593b712020-07-13
0409-6729-41ML - Milliliter0409-6729aa473f16-70c2-4e41-87d0-01c846a41d2d12020-07-13

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
0409-6729MAGNESIUM SULFATE IN WATER INJECTION, SOLUTION [HOSPIRA, INC.]27Current NDC, Legacy NDC, 12 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
1658259magnesium sulfate 2 GM in 50 ML InjectionPSN2e79cf3a-c920-4cc9-bdda-3c7b18853a377
165825950 ML magnesium sulfate 40 MG/ML InjectionSCD2e79cf3a-c920-4cc9-bdda-3c7b18853a377
1658259magnesium sulfate 2 GM per 50 ML InjectionSY2e79cf3a-c920-4cc9-bdda-3c7b18853a377
1658259magnesium sulfate 2 GM in 50 ML InjectionPSN7d94995b-9e2a-0345-e053-2991aa0a62d06
165825950 ML magnesium sulfate 40 MG/ML InjectionSCD7d94995b-9e2a-0345-e053-2991aa0a62d06
1658259magnesium sulfate 2 GM per 50 ML InjectionSY7d94995b-9e2a-0345-e053-2991aa0a62d06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-6729-030040967290324 POUCH in 1 CASE (0409-6729-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG (0409-6729-21) 24 pouch2005-08-220000-00-00NoNoCurrent
0409-6729-090040967290912 POUCH in 1 CASE (0409-6729-09) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG (0409-6729-31) 12 pouch2005-09-280000-00-00NoNoCurrent
0409-6729-110040967291150 mL in 1 BAG50 mlHistorical
0409-6729-2100409672921500 mL in 1 BAG500 mlHistorical
0409-6729-230040967292324 POUCH in 1 CASE (0409-6729-23) / 1 BAG in 1 POUCH / 100 mL in 1 BAG (0409-6729-41) 24 pouch2005-10-130000-00-00NoNoCurrent
0409-6729-240040967292424 POUCH in 1 CASE (0409-6729-24) / 1 BAG in 1 POUCH / 50 mL in 1 BAG (0409-6729-11) 24 pouch2006-11-210000-00-00NoNoCurrent
0409-6729-31004096729311000 mL in 1 BAG1000 mlHistorical
0409-6729-4100409672941100 mL in 1 BAG100 mlHistorical