Magnesium Sulfate
- Product NDC
- 52584-642
- 11-digit product format
- 525840642
- Labeler code
- 52584
- Product ID
- 52584-642_512e413b-44a6-4d26-bec7-5ddeb563f1fd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Magnesium Sulfate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- General Injectables and Vaccines, Inc.
- Application
- NDA019316
- Marketing category
- NDA
- Marketing start
- 2017-01-13
- Marketing end
- 2024-02-29
- Substance
- MAGNESIUM SULFATE HEPTAHYDRATE
- Active strength
- 500 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 52584-642 | D | Discontinued by firm | 2026-08-07 | ||
| excluded package | package | 52584-642 | 52584-642-20 | D | Discontinued by firm | 2026-08-07 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52584-642-20 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52584-642-20 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52584-642-20 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52584-642-20 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52584-642-20 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52584-642-20 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 52584-642-20 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 52584-642-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 52584-642-20 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 52584-642-20 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 52584-642-20 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 52584-642-20 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019316-001 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 1986-09-08 |
| N019316-002 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | 1GM/2ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 1986-09-08 |
| N019316-003 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | 10GM/20ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 2016-01-29 |
| N019316-004 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | 25GM/50ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 2016-01-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N019316-001 | AP |
| N019316-002 | AP |
| N019316-003 | AP |
| N019316-004 | 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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N019316-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 1986-09-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019316-002 | MAGNESIUM SULFATE | 1GM/2ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 1986-09-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019316-003 | MAGNESIUM SULFATE | 10GM/20ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 2016-01-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019316-004 | MAGNESIUM SULFATE | 25GM/50ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 2016-01-29 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019316-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 1986-09-08 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019316-002 | MAGNESIUM SULFATE | 1GM/2ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 1986-09-08 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019316-003 | MAGNESIUM SULFATE | 10GM/20ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 2016-01-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019316-004 | MAGNESIUM SULFATE | 25GM/50ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 2016-01-29 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N019316-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 1986-09-08 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019316-002 | MAGNESIUM SULFATE | 1GM/2ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 1986-09-08 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019316-003 | MAGNESIUM SULFATE | 10GM/20ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 2016-01-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019316-004 | MAGNESIUM SULFATE | 25GM/50ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 2016-01-29 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019316-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 1986-09-08 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019316-002 | MAGNESIUM SULFATE | 1GM/2ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 1986-09-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019316-003 | MAGNESIUM SULFATE | 10GM/20ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 2016-01-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019316-004 | MAGNESIUM SULFATE | 25GM/50ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2016-01-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019316-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 1986-09-08 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019316-002 | MAGNESIUM SULFATE | 1GM/2ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 1986-09-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019316-003 | MAGNESIUM SULFATE | 10GM/20ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 2016-01-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019316-004 | MAGNESIUM SULFATE | 25GM/50ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2016-01-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019316-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 1986-09-08 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019316-002 | MAGNESIUM SULFATE | 1GM/2ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 1986-09-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019316-003 | MAGNESIUM SULFATE | 10GM/20ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 2016-01-29 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019316-004 | MAGNESIUM SULFATE | 25GM/50ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2016-01-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019316-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 1986-09-08 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019316-002 | MAGNESIUM SULFATE | 1GM/2ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 1986-09-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019316-003 | MAGNESIUM SULFATE | 10GM/20ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 2016-01-29 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019316-004 | MAGNESIUM SULFATE | 25GM/50ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2016-01-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019316-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 1986-09-08 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019316-002 | MAGNESIUM SULFATE | 1GM/2ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 1986-09-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019316-003 | MAGNESIUM SULFATE | 10GM/20ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 2016-01-29 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019316-004 | MAGNESIUM SULFATE | 25GM/50ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2016-01-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019316-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 1986-09-08 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019316-002 | MAGNESIUM SULFATE | 1GM/2ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 1986-09-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019316-003 | MAGNESIUM SULFATE | 10GM/20ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 2016-01-29 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019316-004 | MAGNESIUM SULFATE | 25GM/50ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2016-01-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019316-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 1986-09-08 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019316-002 | MAGNESIUM SULFATE | 1GM/2ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 1986-09-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019316-003 | MAGNESIUM SULFATE | 10GM/20ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | RLD, RS | 2016-01-29 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019316-004 | MAGNESIUM SULFATE | 25GM/50ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2016-01-29 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N019316-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019316-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019316-003 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019316-004 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019316-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019316-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019316-003 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019316-004 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N019316-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019316-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019316-003 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019316-004 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019316-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019316-003 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019316-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019316-003 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019316-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019316-003 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019316-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019316-003 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019316-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019316-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019316-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019316-003 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N019316-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019316-003 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019316-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019316-003 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019316-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019316-003 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019316-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019316-003 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N019316-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N019316-003 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019316-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019316-003 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N019316-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N019316-003 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N019316-001 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N019316-003 | AP | 1 | 4b0b4de00fa7… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Magnesium Sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | Fresenius Kabi USA, LLC | e921a46b-9a5b-4163-9c88-224247541f14 | 2026-01-13 | Warnings, Adverse reactions | 019316 NDA019316 |
| Magnesium Sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | Fresenius Kabi USA, LLC | e9c10579-29f3-4889-8881-0626f63968d4 | 2026-01-12 | Warnings, Adverse reactions | 019316 NDA019316 |
| Magnesium Sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | Fresenius Kabi USA, LLC | 6a5d362b-7aa7-40d3-898d-09407cce0713 | 2026-01-08 | Warnings, Adverse reactions | 019316 NDA019316 |
| Magnesium Sulfate | MAGNESIUM SULFATE | Henry Schein, Inc. | c255b8a9-68da-49c1-897b-bc18b731e459 | 2025-10-31 | Warnings | 019316 NDA019316 |
| Magnesium Sulfate | MAGNESIUM SULFATE | Henry Schein, Inc. | 5176ed24-015e-43fe-9eb4-85098debf5f1 | 2025-10-14 | Warnings, Adverse reactions | 019316 NDA019316 |
| Magnesium Sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | ProPharma Distribution | 3f003556-d675-1cf9-e063-6294a90a2cc4 | 2025-09-17 | Warnings, Adverse reactions | 019316 NDA019316 |
| Magnesium Sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | REMEDYREPACK INC. | 8c6b8b3d-9c04-4ed7-86b8-89065b6bf50d | 2025-06-30 | Warnings, Adverse reactions | 019316 NDA019316 |
| Magnesium Sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | ProPharma Distribution | 386d55c9-aeac-5597-e063-6294a90a0afe | 2025-06-25 | Warnings, Adverse reactions | 019316 NDA019316 |
| Magnesium Sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | Medical Purchasing Solutions, LLC | 7978a5b6-0d9c-499e-e053-2a91aa0a06ad | 2023-05-16 | Warnings, Adverse reactions | 019316 NDA019316 |
| MAGNESIUM SULFATE | MAGNESIUM SULFATE | HF Acquisition Co LLC, DBA HealthFirst | 945419b8-6184-f4f3-e053-2a95a90a6236 | 2023-01-27 | Warnings, Adverse reactions | 019316 NDA019316 |
| MAGNESIUM SULFATE | MAGNESIUM SULFATE | HF Acquisition Co LLC, DBA HealthFirst | 94e9a33f-39c4-4bc5-e053-2a95a90a43ac | 2022-12-10 | Warnings, Adverse reactions | 019316 NDA019316 |
| Magnesium Sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | Fresenius Kabi USA, LLC | 77f70e00-3934-4fd9-a581-4cf3df8c42d2 | 2021-12-13 | Warnings, Adverse reactions | 019316 NDA019316 |
| Magnesium Sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | Medical Purchasing Solutions, LLC | b6352fbd-d3ee-2d3a-e053-2a95a90a747d | 2020-12-11 | Warnings, Adverse reactions | 019316 NDA019316 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 52584-642-20 | 52584064220 | 1 VIAL, SINGLE-DOSE in 1 BAG (52584-642-20) > 20 mL in 1 VIAL, SINGLE-DOSE | 2017-01-13 | 0000-00-00 | No | No | Current |