Home NDC 51662-1373 MAGNESIUM SULFATE
Product NDC 51662-1373
11-digit product format 516621373
Labeler code 51662
Product ID 51662-1373_ef7bd6e6-d632-7e93-e053-2a95a90aef83
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MAGNESIUM SULFATE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA206485
Marketing category ANDA
Marketing start 2019-12-09
Substance MAGNESIUM SULFATE HEPTAHYDRATE
Active strength 40 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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206485-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 A206485-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2016-03-15 A206485-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 A206485-004 MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 20GM/500ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 A206485-005 MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 40GM/1000ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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.
Product history page 1 of 6 · 210 observed 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 2026-08-18 06:07:40 2026-07 A206485-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206485-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2016-03-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206485-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206485-004 MAGNESIUM SULFATE IN PLASTIC CONTAINER 20GM/500ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206485-005 MAGNESIUM SULFATE IN PLASTIC CONTAINER 40GM/1000ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206485-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206485-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2016-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206485-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206485-004 MAGNESIUM SULFATE IN PLASTIC CONTAINER 20GM/500ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206485-005 MAGNESIUM SULFATE IN PLASTIC CONTAINER 40GM/1000ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206485-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206485-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2016-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206485-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206485-004 MAGNESIUM SULFATE IN PLASTIC CONTAINER 20GM/500ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206485-005 MAGNESIUM SULFATE IN PLASTIC CONTAINER 40GM/1000ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206485-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206485-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2016-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206485-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206485-004 MAGNESIUM SULFATE IN PLASTIC CONTAINER 20GM/500ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206485-005 MAGNESIUM SULFATE IN PLASTIC CONTAINER 40GM/1000ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206485-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206485-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2016-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206485-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206485-004 MAGNESIUM SULFATE IN PLASTIC CONTAINER 20GM/500ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206485-005 MAGNESIUM SULFATE IN PLASTIC CONTAINER 40GM/1000ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206485-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206485-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2016-03-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206485-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206485-004 MAGNESIUM SULFATE IN PLASTIC CONTAINER 20GM/500ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206485-005 MAGNESIUM SULFATE IN PLASTIC CONTAINER 40GM/1000ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206485-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206485-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2016-03-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206485-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206485-004 MAGNESIUM SULFATE IN PLASTIC CONTAINER 20GM/500ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206485-005 MAGNESIUM SULFATE IN PLASTIC CONTAINER 40GM/1000ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206485-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206485-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2016-03-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206485-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206485-004 MAGNESIUM SULFATE IN PLASTIC CONTAINER 20GM/500ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206485-005 MAGNESIUM SULFATE IN PLASTIC CONTAINER 40GM/1000ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 210 observed states.
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 40 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 1658259 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 51662-1373-1 MAGNESIUM SULFATE 50 mL in 1 BAG INJECTION, SOLUTION 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1373 MAGNESIUM SULFATE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 3 Current NDC, Legacy NDC, 1 package rows 20221211_9947731b-fb0f-0c68-e053-2a95a90a815e.zip
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51662-1373-1 51662137301 50 mL in 1 BAG (51662-1373-1) 50 ml 2019-12-09 0000-00-00 No No Current