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

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
A219777-001MAGNESIUM SULFATEMAGNESIUM SULFATE1GM/2ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28
A219777-002MAGNESIUM SULFATEMAGNESIUM SULFATE5GM/10ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28
A219777-003MAGNESIUM SULFATEMAGNESIUM SULFATE10GM/20ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28
A219777-004MAGNESIUM SULFATEMAGNESIUM SULFATE25GM/50ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A219777-001AP
A219777-002AP
A219777-003AP
A219777-004AP

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
A219777-001CGT2026-02-01
A219777-004CGT2026-02-01

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A219777-001MAGNESIUM SULFATE1GM/2ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07A219777-002MAGNESIUM SULFATE5GM/10ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07A219777-003MAGNESIUM SULFATE10GM/20ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07A219777-004MAGNESIUM SULFATE25GM/50ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219777-001MAGNESIUM SULFATE1GM/2ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219777-002MAGNESIUM SULFATE5GM/10ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219777-003MAGNESIUM SULFATE10GM/20ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219777-004MAGNESIUM SULFATE25GM/50ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219777-001MAGNESIUM SULFATE1GM/2ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219777-002MAGNESIUM SULFATE5GM/10ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219777-003MAGNESIUM SULFATE10GM/20ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219777-004MAGNESIUM SULFATE25GM/50ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A219777-001MAGNESIUM SULFATE1GM/2ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219777-002MAGNESIUM SULFATE5GM/10ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219777-003MAGNESIUM SULFATE10GM/20ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219777-004MAGNESIUM SULFATE25GM/50ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-286a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219777-001MAGNESIUM SULFATE1GM/2ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219777-002MAGNESIUM SULFATE5GM/10ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219777-003MAGNESIUM SULFATE10GM/20ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219777-004MAGNESIUM SULFATE25GM/50ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A219777-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A219777-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A219777-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A219777-004AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219777-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219777-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219777-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219777-004AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219777-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219777-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219777-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219777-004AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219777-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219777-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219777-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219777-004AP16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219777-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219777-002AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219777-003AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219777-004AP1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07A219777-001CGT2026-02-01caaa826d4ba7…
2026-08-18 06:07:402026-07A219777-004CGT2026-02-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219777-001CGT2026-02-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219777-004CGT2026-02-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219777-001CGT2026-02-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219777-004CGT2026-02-0131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219777-001CGT2026-02-01a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219777-004CGT2026-02-01a50c72e98297…

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 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
1658221Internal RxNorm lookup
1658236Internal RxNorm lookup
1658244Internal RxNorm lookup
1658245Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
647ca293-9e68-4773-947a-0fb064aa6fd1Available 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
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

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATECamber Pharmaceuticals, Inc.647ca293-9e68-4773-947a-0fb064aa6fd12025-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219777
application number: ANDA219777
ndc (product): 31722-394

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) 2025-05-28NoNoCurrent
31722-394-333172203943325 VIAL, SINGLE-DOSE in 1 CARTON (31722-394-33) / 10 mL in 1 VIAL, SINGLE-DOSE (31722-394-10) 2025-05-28NoNoCurrent
31722-394-343172203943425 VIAL, SINGLE-DOSE in 1 CARTON (31722-394-34) / 20 mL in 1 VIAL, SINGLE-DOSE (31722-394-20) 2025-05-28NoNoCurrent
31722-394-353172203943525 VIAL, SINGLE-DOSE in 1 CARTON (31722-394-35) / 50 mL in 1 VIAL, SINGLE-DOSE (31722-394-50) 2025-05-28NoNoCurrent
31722-394-503172203945050 mL in 1 VIAL, SINGLE-DOSE50 mlHistorical