Home NDC 31722-394-32 Magnesium Sulfate
Product NDC 31722-394
Requested package NDC 31722-394-32
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 1 .
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 2026-08-01 22:54:32 2026-06 A219777-001 MAGNESIUM SULFATE 1GM/2ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 a50c72e98297…2026-08-01 22:54:32 2026-06 A219777-002 MAGNESIUM SULFATE 5GM/10ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 a50c72e98297…2026-08-01 22:54:32 2026-06 A219777-003 MAGNESIUM SULFATE 10GM/20ML (500MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS AP 2025-05-28 a50c72e98297…2026-08-01 22:54:32 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# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-01 22:54:32 2026-06 A219777-001 CGT 2026-02-01 a50c72e98297…2026-08-01 22:54:32 2026-06 A219777-004 CGT 2026-02-01 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Magnesium Sulfate
Listing expiration 2026-12-31 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1658221 Internal RxNorm lookup 1658236 Internal RxNorm lookup 1658244 Internal RxNorm lookup 1658245 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 31722-394-10 Magnesium Sulfate 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 1 31722-394-20 Magnesium Sulfate 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 20 1 31722-394-31 Magnesium Sulfate 2 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2 1 31722-394-32 Magnesium Sulfate 25 in 1 CARTON INJECTION, SOLUTION 25 1 31722-394-33 Magnesium Sulfate 25 in 1 CARTON INJECTION, SOLUTION 25 1 31722-394-34 Magnesium Sulfate 25 in 1 CARTON INJECTION, SOLUTION 25 1 31722-394-35 Magnesium Sulfate 25 in 1 CARTON INJECTION, SOLUTION 25 1 31722-394-50 Magnesium Sulfate 50 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 50 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 31722-394-32 31722039432 25 VIAL, SINGLE-DOSE in 1 CARTON (31722-394-32) / 2 mL in 1 VIAL, SINGLE-DOSE (31722-394-31) 2025-05-28 No No Current