Magnesium Sulfate

Product NDC
0338-6353
11-digit product format
003386353
Labeler code
0338
Product ID
0338-6353_4607ad92-bf37-439d-92ec-51ee3cdf8318
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Magnesium Sulfate Heptahydrate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
ANDA211966
Marketing category
ANDA
Marketing start
2026-01-08
Substance
MAGNESIUM SULFATE HEPTAHYDRATE
Active strength
3 g/100mL
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211966-001MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATE2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2020-06-01
A211966-002MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATE4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2020-06-01
A211966-003MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATE4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2020-06-01
A211966-004MAGNESIUM SULFATEMAGNESIUM SULFATE3GM/100ML (30MG/ML)INJECTABLE / INJECTIONRS2026-01-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211966-001AP
A211966-002AP
A211966-003AP

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 · 117 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A211966-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2020-06-01caaa826d4ba7…
2026-08-18 06:07:402026-07A211966-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2020-06-01caaa826d4ba7…
2026-08-18 06:07:402026-07A211966-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2020-06-01caaa826d4ba7…
2026-08-18 06:07:402026-07A211966-004MAGNESIUM SULFATE3GM/100ML (30MG/ML)INJECTABLE / INJECTIONRS2026-01-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211966-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2020-06-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211966-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2020-06-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211966-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2020-06-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211966-004MAGNESIUM SULFATE3GM/100ML (30MG/ML)INJECTABLE / INJECTIONRS2026-01-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211966-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2020-06-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211966-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2020-06-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211966-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2020-06-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211966-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2020-06-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211966-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2020-06-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211966-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2020-06-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211966-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2020-06-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211966-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2020-06-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211966-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2020-06-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211966-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2020-06-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211966-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2020-06-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211966-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2020-06-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211966-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2020-06-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211966-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2020-06-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211966-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2020-06-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211966-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2020-06-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211966-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2020-06-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211966-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2020-06-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211966-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2020-06-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211966-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2020-06-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211966-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2020-06-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211966-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2020-06-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211966-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2020-06-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211966-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2020-06-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211966-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2020-06-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A211966-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2020-06-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A211966-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2020-06-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211966-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2020-06-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211966-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2020-06-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211966-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2020-06-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211966-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2020-06-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211966-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2020-06-01301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A211966-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A211966-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A211966-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211966-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211966-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211966-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211966-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211966-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211966-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211966-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211966-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211966-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211966-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211966-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211966-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211966-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211966-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211966-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211966-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211966-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211966-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211966-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211966-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211966-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211966-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211966-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211966-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211966-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211966-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211966-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211966-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211966-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211966-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211966-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211966-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211966-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211966-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211966-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211966-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211966-001AP11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Magnesium Sulfate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM SULFATE HEPTAHYDRATE3 g/100mL

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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
829734Internal RxNorm lookup
1658259Internal RxNorm lookup
1658262Internal RxNorm lookup
2731632Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ea05b8f9-6e11-45c3-824a-4a78818019dfAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-6353-01Magnesium Sulfate100 mL in 1 BAGINJECTION, SOLUTION10012
0338-6353-40Magnesium Sulfate40 in 1 CARTONINJECTION, SOLUTION4012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-6353-01ML - Milliliter0338-6353cec5f71e-93f7-4423-8b28-a5f28882496012026-03-17
0338-6353-40ML - Milliliter0338-6353143a3ad2-80a3-486f-a3bb-9ee131c320fe12026-03-17

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 SulfateMAGNESIUM SULFATE HEPTAHYDRATEBaxter Healthcare Corporationea05b8f9-6e11-45c3-824a-4a78818019df2026-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211966
application number: ANDA211966
ndc (product): 0338-6353
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATECivica, Inc.a5a9f565-639c-4b22-b9e5-718bac7cfcf32025-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211966
application number: ANDA211966

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658259magnesium sulfate 2 GM in 50 ML InjectionPSNea05b8f9-6e11-45c3-824a-4a78818019df12
2731632magnesium sulfate 3 GM in 100 ML InjectionPSNea05b8f9-6e11-45c3-824a-4a78818019df12
1658262magnesium sulfate 4 GM in 100 ML InjectionPSNea05b8f9-6e11-45c3-824a-4a78818019df12
829734magnesium sulfate 4 GM in 50 ML InjectionPSNea05b8f9-6e11-45c3-824a-4a78818019df12
2731632100 ML magnesium sulfate 30 MG/ML InjectionSCDea05b8f9-6e11-45c3-824a-4a78818019df12
1658262100 ML magnesium sulfate 40 MG/ML InjectionSCDea05b8f9-6e11-45c3-824a-4a78818019df12
165825950 ML magnesium sulfate 40 MG/ML InjectionSCDea05b8f9-6e11-45c3-824a-4a78818019df12
82973450 ML magnesium sulfate 80 MG/ML InjectionSCDea05b8f9-6e11-45c3-824a-4a78818019df12
1658259magnesium sulfate 2 GM per 50 ML InjectionSYea05b8f9-6e11-45c3-824a-4a78818019df12
2731632magnesium sulfate 3 GM per 100 ML InjectionSYea05b8f9-6e11-45c3-824a-4a78818019df12
1658262magnesium sulfate 4 GM per 100 ML InjectionSYea05b8f9-6e11-45c3-824a-4a78818019df12
829734magnesium sulfate 4 GM per 50 ML InjectionSYea05b8f9-6e11-45c3-824a-4a78818019df12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0338-6353-0100338635301100 mL in 1 BAG100 mlHistorical
0338-6353-400033863534040 BAG in 1 CARTON (0338-6353-40) / 100 mL in 1 BAG (0338-6353-01) 40 bag2026-01-08NoNoCurrent