Home NDC 63323-107 magnesium sulfate
Product NDC 63323-107
11-digit product format 633230107
Labeler code 63323
Product ID 63323-107_48486022-130e-4a6a-87e7-db7c53eb5e75
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MAGNESIUM SULFATE HEPTAHYDRATE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA206485
Marketing category ANDA
Marketing start 2016-03-15
Substance MAGNESIUM SULFATE HEPTAHYDRATE
Active strength 80 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 43 .
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 · 215 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 2026-09-14 22:38:34 2026-08 A206485-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206485-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2016-03-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206485-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206485-004 MAGNESIUM SULFATE IN PLASTIC CONTAINER 20GM/500ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206485-005 MAGNESIUM SULFATE IN PLASTIC CONTAINER 40GM/1000ML (40MG/ML) INJECTABLE / INJECTION AP 2016-03-15 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 215 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 80 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 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 829734 Internal RxNorm lookup 1658259 Internal RxNorm lookup 1658262 Internal RxNorm lookup 1658264 Internal RxNorm lookup 1658265 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 63323-107-01 magnesium sulfate 50 mL in 1 BAG INJECTION, SOLUTION 50 6 63323-107-05 magnesium sulfate 24 in 1 CASE INJECTION, SOLUTION 24 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-107 MAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20240427_fef9e18c-5210-4090-b564-4950ebe461c0.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 63323-107-01 63323010701 50 mL in 1 BAG 50 ml Historical 63323-107-05 63323010705 24 BAG in 1 CASE (63323-107-05) / 50 mL in 1 BAG (63323-107-01) 24 bag 2016-03-15 0000-00-00 No No Current