Magnesium Sulfate
- Product NDC
- 25021-612
- Requested package NDC
- 25021-612-81
- 11-digit product format
- 250210612
- Labeler code
- 25021
- Product ID
- 25021-612_f91b940b-e459-46c8-886a-c1da0265da54
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Magnesium Sulfate Heptahydrate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA213917
- Marketing category
- ANDA
- Marketing start
- 2021-02-15
- 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 |
|---|---|---|---|---|---|---|---|
| A213917-001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 2GM/50ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | |
| A213917-002 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 4GM/100ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A213917-001 | AP |
| A213917-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A213917-001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 2GM/50ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A213917-002 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 4GM/100ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A213917-001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 2GM/50ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A213917-002 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 4GM/100ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213917-001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 2GM/50ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213917-002 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 4GM/100ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213917-001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 2GM/50ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213917-002 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 4GM/100ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213917-001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 2GM/50ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213917-002 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 4GM/100ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213917-001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 2GM/50ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213917-002 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 4GM/100ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213917-001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 2GM/50ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213917-002 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 4GM/100ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213917-001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 2GM/50ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213917-002 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 4GM/100ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213917-001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 2GM/50ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213917-002 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 4GM/100ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213917-001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 2GM/50ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213917-002 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 4GM/100ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213917-001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 2GM/50ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213917-002 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 4GM/100ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213917-001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 2GM/50ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213917-002 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 4GM/100ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213917-001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 2GM/50ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213917-002 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 4GM/100ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213917-001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 2GM/50ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213917-002 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 4GM/100ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213917-001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 2GM/50ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213917-002 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 4GM/100ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A213917-001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 2GM/50ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A213917-002 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 4GM/100ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213917-001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 2GM/50ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213917-002 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 4GM/100ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A213917-001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 2GM/50ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A213917-002 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 4GM/100ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A213917-001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 2GM/50ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A213917-002 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 4GM/100ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A213917-001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 2GM/50ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A213917-002 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | 4GM/100ML (40MG/ML) | INJECTABLE / INJECTION | AP | 2020-07-10 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A213917-001 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A213917-002 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A213917-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A213917-002 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A213917-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213917-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213917-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213917-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A213917-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213917-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213917-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213917-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213917-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213917-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213917-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213917-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213917-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213917-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213917-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213917-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213917-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213917-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A213917-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213917-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213917-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213917-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213917-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213917-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213917-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213917-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A213917-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A213917-002 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213917-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213917-002 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A213917-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A213917-002 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A213917-001 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A213917-002 | AP | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A213917-001 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A213917-002 | AP | 1 | bb7c543d1eb4… |
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
- 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 |
|---|---|
| a607796c-6676-4d0a-8108-8708fe6769ed | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 25021-612-81 | Magnesium Sulfate | 50 mL in 1 BAG | INJECTION, SOLUTION | 50 | 1 | |
| 25021-612-81 | Magnesium Sulfate | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | 1 | |
| 25021-612-82 | Magnesium Sulfate | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | 1 | |
| 25021-612-82 | Magnesium Sulfate | 100 mL in 1 BAG | INJECTION, SOLUTION | 100 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 25021-612-81 | ML - Milliliter | 25021-612 | d0b6eb28-d718-4f07-8788-1e3bd80128ef | 1 | 2021-05-05 |
| 25021-612-82 | ML - Milliliter | 25021-612 | 81de6140-fa14-4125-babb-fd21bcbe16a4 | 1 | 2021-05-05 |
DailyMed Dashboard NDC Coverage#
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 | Sun Pharmaceutical Industries, Inc. | efadcb55-f935-4c60-b2e2-0a76b9194b50 | 2026-01-29 | Warnings, Adverse reactions | 213917 ANDA213917 |
| Magnesium Sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | Sagent Pharmaceuticals | a607796c-6676-4d0a-8108-8708fe6769ed | 2020-11-16 | Warnings, Adverse reactions | 213917 ANDA213917 25021-612-81 25021-612 25021061281 |
| MAGNESIUM SULFATE | MAGNESIUM SULFATE HEPTAHYDRATE | Gland Pharma Limited | a9e706ac-9c5f-4b14-b277-53dee195ffc6 | 2020-07-14 | Warnings, Adverse reactions | 213917 ANDA213917 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1658259 | magnesium sulfate 2 GM in 50 ML Injection | PSN | a607796c-6676-4d0a-8108-8708fe6769ed | 1 |
| 1658262 | magnesium sulfate 4 GM in 100 ML Injection | PSN | a607796c-6676-4d0a-8108-8708fe6769ed | 1 |
| 1658262 | 100 ML magnesium sulfate 40 MG/ML Injection | SCD | a607796c-6676-4d0a-8108-8708fe6769ed | 1 |
| 1658259 | 50 ML magnesium sulfate 40 MG/ML Injection | SCD | a607796c-6676-4d0a-8108-8708fe6769ed | 1 |
| 1658259 | magnesium sulfate 2 GM per 50 ML Injection | SY | a607796c-6676-4d0a-8108-8708fe6769ed | 1 |
| 1658262 | magnesium sulfate 4 GM per 100 ML Injection | SY | a607796c-6676-4d0a-8108-8708fe6769ed | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 25021-612-81 | 25021061281 | 10 BAG in 1 CARTON (25021-612-81) / 50 mL in 1 BAG | 10 bag | 2021-02-15 | 0000-00-00 | No | No | Current |