FDA.reportPublic FDA data

Magnesium Sulfate in Water

Product NDC
70860-501
11-digit product format
708600501
Labeler code
70860
Product ID
70860-501_12dd1cea-ace9-f3b7-e063-6294a90a34ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
magnesium sulfate in water
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Athenex Pharmaceutical Division, LLC.
Application
ANDA209642
Marketing category
ANDA
Marketing start
2023-01-31
Marketing end
2027-01-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Magnesium Sulfate in Water

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM SULFATE HEPTAHYDRATE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSK47B8698T
Rxcui829734, 1658259, 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70860-501-812024-03-04C16284748780-11030e365-0fec-111a-e063-dadaa90a10e2Magnesium Sulfate in Water for Injection (For Intravenous Use)
70860-501-822024-03-04C16284748780-11030e365-0fec-111a-e063-dadaa90a10e2Magnesium Sulfate in Water for Injection (For Intravenous Use)
70860-501-812024-01-30C16284748780-11030e365-0fec-111a-e063-dadaa90a10e2Magnesium Sulfate in Water for Injection (For Intravenous Use)
70860-501-822024-01-30C16284748780-11030e365-0fec-111a-e063-dadaa90a10e2Magnesium Sulfate in Water for Injection (For Intravenous Use)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70860-501-41Magnesium Sulfate in Water1 in 1 POUCHINJECTION, SOLUTION12
70860-501-41Magnesium Sulfate in Water50 mL in 1 BAGINJECTION, SOLUTION502
70860-501-42Magnesium Sulfate in Water1 in 1 POUCHINJECTION, SOLUTION12
70860-501-42Magnesium Sulfate in Water100 mL in 1 BAGINJECTION, SOLUTION1002
70860-501-81Magnesium Sulfate in Water24 in 1 CARTONINJECTION, SOLUTION242
70860-501-82Magnesium Sulfate in Water24 in 1 CARTONINJECTION, SOLUTION242

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70860-501-41ML - Milliliter70860-50135634aa7-dba4-4c2b-920d-6fcfa8700e0112023-04-07
70860-501-42ML - Milliliter70860-5017823ca03-134a-48e7-befd-39b711fd1d4a12023-04-07
70860-501-81ML - Milliliter70860-50134f4418d-d207-4734-bbd3-5fd9ca31525612023-03-13
70860-501-82ML - Milliliter70860-50103d5dea7-f28e-4052-a4cb-1b4ec3c2d92712023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70860-501MAGNESIUM SULFATE IN WATER INJECTION, SOLUTION [ATHENEX PHARMACEUTICAL DIVISION, LLC.]2Current NDC, 6 package rows20240306_70776952-a340-4405-9cf0-f0988ff8097b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658259magnesium sulfate 2 GM in 50 ML InjectionPSN70776952-a340-4405-9cf0-f0988ff8097b2
1658262magnesium sulfate 4 GM in 100 ML InjectionPSN70776952-a340-4405-9cf0-f0988ff8097b2
829734magnesium sulfate 4 GM in 50 ML InjectionPSN70776952-a340-4405-9cf0-f0988ff8097b2
1658262100 ML magnesium sulfate 40 MG/ML InjectionSCD70776952-a340-4405-9cf0-f0988ff8097b2
165825950 ML magnesium sulfate 40 MG/ML InjectionSCD70776952-a340-4405-9cf0-f0988ff8097b2
82973450 ML magnesium sulfate 80 MG/ML InjectionSCD70776952-a340-4405-9cf0-f0988ff8097b2
1658259magnesium sulfate 2 GM per 50 ML InjectionSY70776952-a340-4405-9cf0-f0988ff8097b2
1658262magnesium sulfate 4 GM per 100 ML InjectionSY70776952-a340-4405-9cf0-f0988ff8097b2
829734magnesium sulfate 4 GM per 50 ML InjectionSY70776952-a340-4405-9cf0-f0988ff8097b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70860-501-41708600501411 in 1 POUCHHistorical
70860-501-42708600501421 in 1 POUCHHistorical
70860-501-817086005018124 POUCH in 1 CARTON (70860-501-81) / 1 BAG in 1 POUCH (70860-501-41) / 50 mL in 1 BAG24 pouch2023-01-312027-01-31NoNoHistorical
70860-501-827086005018224 POUCH in 1 CARTON (70860-501-82) / 1 BAG in 1 POUCH (70860-501-42) / 100 mL in 1 BAG24 pouch2023-01-312026-12-31NoNoHistorical