Magnesium Sulfate in Water

Product NDC
70860-502
11-digit product format
708600502
Labeler code
70860
Product ID
70860-502_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
2026-10-31
Substance
MAGNESIUM SULFATE HEPTAHYDRATE
Active strength
80 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209642-001MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATE2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-08
A209642-002MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATE4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-08
A209642-003MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATE4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2021-11-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A209642-001AP
A209642-002AP
A209642-003AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A209642-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209642-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209642-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2021-11-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209642-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209642-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209642-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2021-11-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A209642-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209642-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209642-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2021-11-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209642-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209642-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209642-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2021-11-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209642-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209642-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209642-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2021-11-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209642-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209642-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209642-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2021-11-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209642-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209642-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209642-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2021-11-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209642-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209642-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209642-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2021-11-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209642-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209642-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209642-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2021-11-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209642-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A209642-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A209642-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2021-11-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209642-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209642-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209642-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2021-11-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209642-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209642-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209642-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2021-11-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209642-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209642-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209642-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2021-11-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209642-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2021-11-088072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A209642-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209642-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209642-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209642-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209642-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209642-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209642-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209642-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209642-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209642-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209642-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209642-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209642-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209642-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209642-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209642-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209642-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209642-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209642-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209642-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209642-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209642-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209642-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209642-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209642-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209642-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209642-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209642-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209642-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209642-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209642-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209642-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209642-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209642-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209642-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209642-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209642-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209642-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209642-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209642-001AP18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Magnesium Sulfate in Water

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM SULFATE HEPTAHYDRATE80 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SK47B8698TInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
829734Internal RxNorm lookup
1658259Internal RxNorm lookup
1658262Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
70776952-a340-4405-9cf0-f0988ff8097bAvailable on FDA.report

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70860-502-41Magnesium Sulfate in Water1 in 1 POUCHINJECTION, SOLUTION12
70860-502-41Magnesium Sulfate in Water50 mL in 1 BAGINJECTION, SOLUTION502
70860-502-81Magnesium Sulfate in Water24 in 1 CARTONINJECTION, SOLUTION242

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70860-502-41ML - Milliliter70860-502cd17ea9f-7ed3-4b96-84eb-b0ea37c072df12023-04-07
70860-502-81ML - Milliliter70860-502a80d7227-7aa0-46bd-8a33-7ce831d24cec12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70860-502MAGNESIUM SULFATE IN WATER INJECTION, SOLUTION [ATHENEX PHARMACEUTICAL DIVISION, LLC.]2Current NDC, 3 package rows20240306_70776952-a340-4405-9cf0-f0988ff8097b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERAvenacy, LLCf50f4e06-288c-4b5e-9260-f3fe0a210c0c2025-09-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209642
application number: ANDA209642
Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERAthenex Pharmaceutical Division, LLC.70776952-a340-4405-9cf0-f0988ff8097b2024-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209642
application number: ANDA209642
ndc (product): 70860-502

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
70860-502-41708600502411 in 1 POUCHHistorical
70860-502-817086005028124 POUCH in 1 CARTON (70860-502-81) / 1 BAG in 1 POUCH (70860-502-41) / 50 mL in 1 BAG24 pouch2023-01-312026-10-31NoNoHistorical