Home NDC 76483-129 Magnesium Sulfate
Product NDC 76483-129
11-digit product format 764830129
Labeler code 76483
Product ID 76483-129_878a167e-0654-43a3-9d0b-3e5b4724e257
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Magnesium Sulfate Heptahydrate
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler SQUARE PHARMACEUTICALS PLC.
Application ANDA217461
Marketing category ANDA
Marketing start 2026-10-30
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 44 .
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 A217461-001 MAGNESIUM SULFATE MAGNESIUM SULFATE 1GM/2ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2026-07-09 A217461-002 MAGNESIUM SULFATE MAGNESIUM SULFATE 5GM/10ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2026-07-09 A217461-003 MAGNESIUM SULFATE MAGNESIUM SULFATE 10GM/20ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2026-07-09 A217461-004 MAGNESIUM SULFATE MAGNESIUM SULFATE 25GM/50ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2026-07-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 2026-10-15 13:18:30 2026-09 A217461-001 MAGNESIUM SULFATE 1GM/2ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2026-07-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 A217461-002 MAGNESIUM SULFATE 5GM/10ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2026-07-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 A217461-003 MAGNESIUM SULFATE 10GM/20ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2026-07-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 A217461-004 MAGNESIUM SULFATE 25GM/50ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2026-07-09 c2088c7a36db…2026-09-14 22:38:34 2026-08 A217461-001 MAGNESIUM SULFATE 1GM/2ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2026-07-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217461-002 MAGNESIUM SULFATE 5GM/10ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2026-07-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217461-003 MAGNESIUM SULFATE 10GM/20ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2026-07-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217461-004 MAGNESIUM SULFATE 25GM/50ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2026-07-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217461-001 MAGNESIUM SULFATE 1GM/2ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2026-07-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217461-002 MAGNESIUM SULFATE 5GM/10ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2026-07-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217461-003 MAGNESIUM SULFATE 10GM/20ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2026-07-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217461-004 MAGNESIUM SULFATE 25GM/50ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2026-07-09 caaa826d4ba7…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 76483-129-01 76483012901 25 VIAL in 1 CARTON (76483-129-01) / 2 mL in 1 VIAL (76483-129-00) 25 vial 2026-10-30 No No Historical 76483-129-03 76483012903 25 VIAL in 1 CARTON (76483-129-03) / 10 mL in 1 VIAL (76483-129-02) 25 vial 2026-10-30 No No Historical 76483-129-05 76483012905 25 VIAL in 1 CARTON (76483-129-05) / 20 mL in 1 VIAL (76483-129-04) 25 vial 2026-10-30 No No Historical 76483-129-07 76483012907 25 VIAL in 1 CARTON (76483-129-07) / 50 mL in 1 VIAL (76483-129-06) 25 vial 2026-10-30 No No Historical