magnesium sulfate
- Product NDC
- 63323-106
- 11-digit product format
- 633230106
- Labeler code
- 63323
- Product ID
- 63323-106_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
- 40 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
Orange Book products#
| 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#
| Application-product | TE code |
|---|---|
| A206485-001 | AP |
| A206485-002 | AP |
| A206485-003 | AP |
| A206485-004 | AP |
| A206485-005 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 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… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206485-001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 4GM/100ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2016-03-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206485-002 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 4GM/50ML (80MG/ML) | INJECTABLE / INJECTION | AP | 2016-03-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206485-003 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 2GM/50ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2016-03-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206485-004 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 20GM/500ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2016-03-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206485-005 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 40GM/1000ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2016-03-15 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A206485-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206485-002 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206485-003 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206485-004 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206485-005 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A206485-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206485-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206485-003 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206485-004 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206485-005 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206485-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206485-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206485-003 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206485-004 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206485-005 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A206485-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206485-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206485-003 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206485-004 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206485-005 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206485-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206485-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206485-003 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206485-004 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206485-005 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206485-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206485-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206485-003 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206485-004 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206485-005 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206485-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206485-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206485-003 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206485-004 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206485-005 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206485-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206485-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206485-003 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206485-004 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206485-005 | AP | 1 | 2680178bc6a6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- magnesium sulfate
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MAGNESIUM SULFATE HEPTAHYDRATE | 40 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SK47B8698T | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| fef9e18c-5210-4090-b564-4950ebe461c0 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63323-106-00 | magnesium sulfate | 100 mL in 1 BAG | INJECTION, SOLUTION | 100 | 6 | |
| 63323-106-01 | magnesium sulfate | 24 in 1 CASE | INJECTION, SOLUTION | 24 | 6 | |
| 63323-106-02 | magnesium sulfate | 50 mL in 1 BAG | INJECTION, SOLUTION | 50 | 6 | |
| 63323-106-05 | magnesium sulfate | 24 in 1 CASE | INJECTION, SOLUTION | 24 | 6 | |
| 63323-106-10 | magnesium sulfate | 1000 mL in 1 BAG | INJECTION, SOLUTION | 1000 | 6 | |
| 63323-106-10 | magnesium sulfate | 24 in 1 CASE | INJECTION, SOLUTION | 24 | 6 | |
| 63323-106-15 | magnesium sulfate | 24 in 1 CASE | INJECTION, SOLUTION | 24 | 6 | |
| 63323-106-15 | magnesium sulfate | 500 mL in 1 BAG | INJECTION, SOLUTION | 500 | 6 | |
| 63323-106-03 | magnesium sulfate | 50 mL in 1 BAG | INJECTION, SOLUTION | 50 | 4 | |
| 63323-106-26 | magnesium sulfate | 24 in 1 CASE | INJECTION, SOLUTION | 24 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63323-106-00 | ML - Milliliter | 63323-106 | 9ace8689-931a-4197-9319-b72bd2a37ae6 | 1 | 2020-08-06 |
| 63323-106-01 | ML - Milliliter | 63323-106 | 7f8b40d2-995b-4c49-ade4-80b88379609e | 1 | 2016-07-19 |
| 63323-106-02 | ML - Milliliter | 63323-106 | b3bde1aa-065e-4b32-9b7a-bca6702d956e | 1 | 2020-08-06 |
| 63323-106-03 | ML - Milliliter | 63323-106 | 30edc205-da2b-48e7-b0a9-987df29b33c6 | 1 | 2020-08-06 |
| 63323-106-05 | ML - Milliliter | 63323-106 | 160cd784-d21d-453d-b23c-c3aa6833bc0c | 1 | 2016-07-19 |
| 63323-106-10 | ML - Milliliter | 63323-106 | 6e3762be-c4ef-4162-8a4e-07b4fd046a0e | 1 | 2016-07-19 |
| 63323-106-15 | ML - Milliliter | 63323-106 | 77c09967-5056-42c9-98c0-ad67545c2e83 | 1 | 2016-07-19 |
| 63323-106-26 | ML - Milliliter | 63323-106 | e55caef4-abd3-4bdd-901b-26167f975e42 | 1 | 2017-04-05 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63323-106 | MAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 6 | Current NDC, Legacy NDC, 8 package rows | 20240427_fef9e18c-5210-4090-b564-4950ebe461c0.zip |
| 63323-106 | MAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240427_43d658b1-2b19-44be-a346-cac11fd600b3.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| magnesium sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | Fresenius Kabi USA, LLC | fef9e18c-5210-4090-b564-4950ebe461c0 | 2024-04-24 | Warnings, Adverse reactions | 206485 ANDA206485 63323-106 |
| magnesium sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | Fresenius Kabi USA, LLC | 43d658b1-2b19-44be-a346-cac11fd600b3 | 2024-04-24 | Warnings, Adverse reactions | 206485 ANDA206485 63323-106 |
| MAGNESIUM SULFATE | MAGNESIUM SULFATE | HF Acquisition Co LLC, DBA HealthFirst | 9947731b-fb0f-0c68-e053-2a95a90a815e | 2022-12-10 | Warnings, Adverse reactions | 206485 ANDA206485 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1658259 | magnesium sulfate 2 GM in 50 ML Injection | PSN | fef9e18c-5210-4090-b564-4950ebe461c0 | 6 |
| 1658264 | magnesium sulfate 20 GM in 500 ML Injection | PSN | fef9e18c-5210-4090-b564-4950ebe461c0 | 6 |
| 1658262 | magnesium sulfate 4 GM in 100 ML Injection | PSN | fef9e18c-5210-4090-b564-4950ebe461c0 | 6 |
| 829734 | magnesium sulfate 4 GM in 50 ML Injection | PSN | fef9e18c-5210-4090-b564-4950ebe461c0 | 6 |
| 1658265 | magnesium sulfate 40 GM in 1000 ML Injection | PSN | fef9e18c-5210-4090-b564-4950ebe461c0 | 6 |
| 1658262 | 100 ML magnesium sulfate 40 MG/ML Injection | SCD | fef9e18c-5210-4090-b564-4950ebe461c0 | 6 |
| 1658265 | 1000 ML magnesium sulfate 40 MG/ML Injection | SCD | fef9e18c-5210-4090-b564-4950ebe461c0 | 6 |
| 1658259 | 50 ML magnesium sulfate 40 MG/ML Injection | SCD | fef9e18c-5210-4090-b564-4950ebe461c0 | 6 |
| 829734 | 50 ML magnesium sulfate 80 MG/ML Injection | SCD | fef9e18c-5210-4090-b564-4950ebe461c0 | 6 |
| 1658264 | 500 ML magnesium sulfate 40 MG/ML Injection | SCD | fef9e18c-5210-4090-b564-4950ebe461c0 | 6 |
| 1658259 | magnesium sulfate 2 GM per 50 ML Injection | SY | fef9e18c-5210-4090-b564-4950ebe461c0 | 6 |
| 1658264 | magnesium sulfate 20 GM per 500 ML Injection | SY | fef9e18c-5210-4090-b564-4950ebe461c0 | 6 |
| 1658262 | magnesium sulfate 4 GM per 100 ML Injection | SY | fef9e18c-5210-4090-b564-4950ebe461c0 | 6 |
| 829734 | magnesium sulfate 4 GM per 50 ML Injection | SY | fef9e18c-5210-4090-b564-4950ebe461c0 | 6 |
| 1658265 | magnesium sulfate 40 GM per 1000 ML Injection | SY | fef9e18c-5210-4090-b564-4950ebe461c0 | 6 |
| 1658259 | magnesium sulfate 2 GM in 50 ML Injection | PSN | 43d658b1-2b19-44be-a346-cac11fd600b3 | 4 |
| 1658264 | magnesium sulfate 20 GM in 500 ML Injection | PSN | 43d658b1-2b19-44be-a346-cac11fd600b3 | 4 |
| 1658262 | magnesium sulfate 4 GM in 100 ML Injection | PSN | 43d658b1-2b19-44be-a346-cac11fd600b3 | 4 |
| 1658265 | magnesium sulfate 40 GM in 1000 ML Injection | PSN | 43d658b1-2b19-44be-a346-cac11fd600b3 | 4 |
| 1658262 | 100 ML magnesium sulfate 40 MG/ML Injection | SCD | 43d658b1-2b19-44be-a346-cac11fd600b3 | 4 |
| 1658265 | 1000 ML magnesium sulfate 40 MG/ML Injection | SCD | 43d658b1-2b19-44be-a346-cac11fd600b3 | 4 |
| 1658259 | 50 ML magnesium sulfate 40 MG/ML Injection | SCD | 43d658b1-2b19-44be-a346-cac11fd600b3 | 4 |
| 1658264 | 500 ML magnesium sulfate 40 MG/ML Injection | SCD | 43d658b1-2b19-44be-a346-cac11fd600b3 | 4 |
| 1658259 | magnesium sulfate 2 GM per 50 ML Injection | SY | 43d658b1-2b19-44be-a346-cac11fd600b3 | 4 |
| 1658264 | magnesium sulfate 20 GM per 500 ML Injection | SY | 43d658b1-2b19-44be-a346-cac11fd600b3 | 4 |
| 1658262 | magnesium sulfate 4 GM per 100 ML Injection | SY | 43d658b1-2b19-44be-a346-cac11fd600b3 | 4 |
| 1658265 | magnesium sulfate 40 GM per 1000 ML Injection | SY | 43d658b1-2b19-44be-a346-cac11fd600b3 | 4 |
| 1658259 | magnesium sulfate 2 GM in 50 ML Injection | PSN | 9947731b-fb0f-0c68-e053-2a95a90a815e | 3 |
| 1658259 | 50 ML magnesium sulfate 40 MG/ML Injection | SCD | 9947731b-fb0f-0c68-e053-2a95a90a815e | 3 |
| 1658259 | magnesium sulfate 2 GM per 50 ML Injection | SY | 9947731b-fb0f-0c68-e053-2a95a90a815e | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63323-106-00 | 63323010600 | 100 mL in 1 BAG | 100 ml | Historical | ||||
| 63323-106-01 | 63323010601 | 24 BAG in 1 CASE (63323-106-01) / 100 mL in 1 BAG (63323-106-00) | 24 bag | 2016-03-15 | 0000-00-00 | No | No | Current |
| 63323-106-02 | 63323010602 | 50 mL in 1 BAG | 50 ml | Historical | ||||
| 63323-106-03 | 63323010603 | 50 mL in 1 BAG | 50 ml | Historical | ||||
| 63323-106-05 | 63323010605 | 24 BAG in 1 CASE (63323-106-05) / 50 mL in 1 BAG (63323-106-02) | 24 bag | 2016-03-15 | 0000-00-00 | No | No | Current |
| 63323-106-10 | 63323010610 | 24 BAG in 1 CASE (63323-106-10) / 1000 mL in 1 BAG | 24 bag | 2016-03-15 | 0000-00-00 | No | No | Current |
| 63323-106-15 | 63323010615 | 24 BAG in 1 CASE (63323-106-15) / 500 mL in 1 BAG | 24 bag | 2016-03-15 | 0000-00-00 | No | No | Current |
| 63323-106-26 | 63323010626 | 24 BAG in 1 CASE (63323-106-26) / 50 mL in 1 BAG (63323-106-03) | 24 bag | 2016-03-15 | 0000-00-00 | No | No | Current |