Home NDC 71872-7381-1 Magnesium Sulfate
Product NDC 71872-7381
Requested package NDC 71872-7381-1
11-digit product format 718727381
Labeler code 71872
Product ID 71872-7381_5a0f9db9-b8bf-c923-e063-6394a90a7dd7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Magnesium sulfate heptahydrate
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Medical Purchasing Solutions, LLC
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219777-001 MAGNESIUM SULFATE MAGNESIUM SULFATE 1GM/2ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 A219777-002 MAGNESIUM SULFATE MAGNESIUM SULFATE 5GM/10ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 A219777-003 MAGNESIUM SULFATE MAGNESIUM SULFATE 10GM/20ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 A219777-004 MAGNESIUM SULFATE MAGNESIUM SULFATE 25GM/50ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A219777-001 CGT 2026-02-01 A219777-004 CGT 2026-02-01
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A219777-001 MAGNESIUM SULFATE 1GM/2ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219777-002 MAGNESIUM SULFATE 5GM/10ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219777-003 MAGNESIUM SULFATE 10GM/20ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219777-004 MAGNESIUM SULFATE 25GM/50ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219777-001 MAGNESIUM SULFATE 1GM/2ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219777-002 MAGNESIUM SULFATE 5GM/10ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219777-003 MAGNESIUM SULFATE 10GM/20ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219777-004 MAGNESIUM SULFATE 25GM/50ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219777-001 MAGNESIUM SULFATE 1GM/2ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219777-002 MAGNESIUM SULFATE 5GM/10ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219777-003 MAGNESIUM SULFATE 10GM/20ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219777-004 MAGNESIUM SULFATE 25GM/50ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219777-001 MAGNESIUM SULFATE 1GM/2ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219777-002 MAGNESIUM SULFATE 5GM/10ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219777-003 MAGNESIUM SULFATE 10GM/20ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219777-004 MAGNESIUM SULFATE 25GM/50ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219777-001 MAGNESIUM SULFATE 1GM/2ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219777-002 MAGNESIUM SULFATE 5GM/10ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219777-003 MAGNESIUM SULFATE 10GM/20ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219777-004 MAGNESIUM SULFATE 25GM/50ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219777-001 MAGNESIUM SULFATE 1GM/2ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219777-002 MAGNESIUM SULFATE 5GM/10ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219777-003 MAGNESIUM SULFATE 10GM/20ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219777-004 MAGNESIUM SULFATE 25GM/50ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Magnesium Sulfate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MAGNESIUM SULFATE HEPTAHYDRATE 500 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SK47B8698T Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1658221 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71872-7381-1 71872738101 1 VIAL, SINGLE-DOSE in 1 BAG (71872-7381-1) / 2 mL in 1 VIAL, SINGLE-DOSE 2026-08-27 No No Current