Home NDC 70860-502-81 Magnesium Sulfate in Water
Product NDC 70860-502
Requested package NDC 70860-502-81
11-digit product format 708600502
Labeler code 70860
Product ID 70860-502_12dd1cea-ace9-f3b7-e063-6294a90a34ec
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name magnesium sulfate in water
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Athenex Pharmaceutical Division, LLC.
Application ANDA209642
Marketing category ANDA
Marketing start 2023-01-31
Marketing end 2026-10-31
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
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209642-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 A209642-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 A209642-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2021-11-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 3 · 105 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 A209642-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209642-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209642-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2021-11-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209642-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209642-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209642-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2021-11-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209642-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209642-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209642-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2021-11-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209642-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209642-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209642-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2021-11-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209642-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209642-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209642-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2021-11-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209642-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209642-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209642-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2021-11-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209642-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209642-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209642-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2021-11-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209642-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209642-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209642-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2021-11-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209642-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209642-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209642-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2021-11-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209642-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209642-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209642-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2021-11-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209642-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209642-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209642-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2021-11-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209642-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209642-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209642-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2021-11-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209642-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209642-002 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/100ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209642-003 MAGNESIUM SULFATE IN PLASTIC CONTAINER 4GM/50ML (80MG/ML) INJECTABLE / INJECTION AP 2021-11-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209642-001 MAGNESIUM SULFATE IN PLASTIC CONTAINER 2GM/50ML (40MG/ML) INJECTABLE / INJECTION AP 2021-11-08 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 96 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Magnesium Sulfate in Water 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 829734 Internal RxNorm lookup 1658259 Internal RxNorm lookup 1658262 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70860-502-41 Magnesium Sulfate in Water 1 in 1 POUCH INJECTION, SOLUTION 1 2 70860-502-41 Magnesium Sulfate in Water 50 mL in 1 BAG INJECTION, SOLUTION 50 2 70860-502-81 Magnesium Sulfate in Water 24 in 1 CARTON INJECTION, SOLUTION 24 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70860-502 MAGNESIUM SULFATE IN WATER INJECTION, SOLUTION [ATHENEX PHARMACEUTICAL DIVISION, LLC.] 2 Current NDC, 3 package rows 20240306_70776952-a340-4405-9cf0-f0988ff8097b.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 · 2 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 70860-502-81 70860050281 24 POUCH in 1 CARTON (70860-502-81) / 1 BAG in 1 POUCH (70860-502-41) / 50 mL in 1 BAG 24 pouch 2023-01-31 2026-10-31 No No Historical