Home NDC 67457-553 Magnesium Sulfate
Product NDC 67457-553
11-digit product format 674570553
Labeler code 67457
Product ID 67457-553_9b7bc3cc-7e45-422e-bc80-0add7e82fb4b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MAGNESIUM SULFATE HEPTAHYDRATE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Mylan Institutional LLC
Application ANDA209911
Marketing category ANDA
Marketing start 2020-10-02
Marketing end 0000-00-00
Substance MAGNESIUM SULFATE HEPTAHYDRATE
Active strength 2 g/50mL
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 2024-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209911-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 2GM/50ML (40MG/ML) INJECTABLE / INJECTION 2018-09-14 A209911-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 4GM/100ML (40MG/ML) INJECTABLE / INJECTION 2018-09-14
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 3 · 86 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 A209911-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION 2018-09-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209911-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION 2018-09-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209911-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION 2018-09-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209911-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION 2018-09-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209911-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209911-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION 2018-09-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209911-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209911-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION 2018-09-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209911-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209911-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209911-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209911-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209911-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209911-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209911-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209911-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209911-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209911-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209911-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209911-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209911-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209911-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209911-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209911-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209911-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209911-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209911-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209911-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209911-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209911-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209911-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209911-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209911-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209911-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209911-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A209911-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209911-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A209911-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209911-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A209911-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2018-09-14 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-553 MAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] 4 Legacy NDC 20250104_297cae36-9935-4f7c-8039-5401992f5768.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67457-553-00 67457055300 1 BAG in 1 POUCH (67457-553-00) > 50 mL in 1 BAG 1 bag 2020-10-02 0000-00-00 No No Current