Home NDC 0264-4400 Magnesium Sulfate in Dextrose
Product NDC 0264-4400
11-digit product format 002644400
Labeler code 0264
Product ID 0264-4400_27f278a7-1ccc-4f74-99bd-2e9c806d4663
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name magnesium sulfate heptahydrate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler B. Braun Medical Inc.
Application ANDA207966
Marketing category ANDA
Marketing start 2020-10-27
Substance MAGNESIUM SULFATE HEPTAHYDRATE
Active strength 10 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER MAGNESIUM SULFATE 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207966-001 AP
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 2026-08-18 06:07:40 2026-07 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 8869cabd3fbd…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207966-001 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER 1GM/100ML INJECTABLE / INJECTION AP 2020-10-27 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Magnesium Sulfate in Dextrose
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MAGNESIUM SULFATE HEPTAHYDRATE 10 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 829757 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 0264-4400-54 Magnesium Sulfate in Dextrose 24 in 1 CASE INJECTION, SOLUTION 24 8 0264-4400-54 Magnesium Sulfate in Dextrose 100 mL in 1 CONTAINER INJECTION, SOLUTION 100 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0264-4400 MAGNESIUM SULFATE IN DEXTROSE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.] 7 Current NDC, Legacy NDC, 2 package rows 20210408_4876dcd9-5e8f-47ed-af4f-6a4009ccffd1.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 · 1 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 0264-4400-54 00264440054 24 CONTAINER in 1 CASE (0264-4400-54) / 100 mL in 1 CONTAINER 24 container 2020-10-27 0000-00-00 No No Current