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NDC 67457-0134-50 Magnesium Chloride 200 mg/mL Details
Magnesium Chloride 200 mg/mL
Magnesium Chloride is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Institutional LLC. The primary component is MAGNESIUM CHLORIDE.
Product Information
| NDC | 67457-0134 |
|---|---|
| Product ID | 67457-134_46f389a6-b16b-44af-b468-973805cc3c49 |
| Associated GPIs | 79400010202015 |
| GCN Sequence Number | 001400 |
| GCN Sequence Number Description | magnesium chloride VIAL 200 MG/ML INJECTION |
| HIC3 | C1H |
| HIC3 Description | MAGNESIUM SALTS REPLACEMENT |
| GCN | 04050 |
| HICL Sequence Number | 000607 |
| HICL Sequence Number Description | MAGNESIUM CHLORIDE |
| Brand/Generic | Generic |
| Proprietary Name | Magnesium Chloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | magnesium chloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/mL |
| Substance Name | MAGNESIUM CHLORIDE |
| Labeler Name | Mylan Institutional LLC |
| Pharmaceutical Class | 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 |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 67457-0134-50 (67457013450)
| NDC Package Code | 67457-134-50 |
|---|---|
| Billing NDC | 67457013450 |
| Package | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-134-50) / 50 mL in 1 VIAL, MULTI-DOSE |
| Marketing Start Date | 2013-03-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 2105d1c1-54ef-4d1a-a63c-b1619e8b50db Details
DESCRIPTION
Magnesium Chloride Injection is a sterile solution of Magnesium Chloride Hexahydrate in Water for Injection q.s. Each mL contains Magnesium Chloride Hexahydrate 200 mg, Sodium Chloride 9 mg, Benzyl Alcohol 1% as a preservative, Water for Injection, q.s. pH adjusted with Hydrochloric Acid and/or Sodium Hydroxide. Total osmolarity equivalent to 2.951 mOsm/mL.
Contains 1.97 mEq of Mg++ and Cl- per mL.
The structural formula is MgCl2•6H2O
ACTIONS
CONTRAINDICATIONS
PRECAUTIONS
The usual precautions for parenteral administration should be observed. Administer with caution if flushing and sweating occurs. A preparation of a calcium salt should be readily available for intravenous injection to counteract potential serious signs of magnesium intoxication. As long as deep tendon reflexes are active it is probable that the patient will not develop respiratory paralysis. Respiration and blood pressure should be carefully observed during and after administration of Magnesium Chloride Injection.
Pregnancy
Animal reproduction studies have not been conducted with magnesium chloride. It is also not known whether magnesium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Magnesium Chloride should be given to a pregnant woman only if clearly needed.
ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION
USUAL DOSAGE RANGE
HOW SUPPLIED
Magnesium Chloride Injection 200 mg/mL (20% w/v).
NDC 67457-134-50
50 mL Multiple-Dose Vial. Individually boxed.
Store at 20° to 25°C (68° to 77°F). [See USP Controlled
Room Temperature.]
Manufactured for:
Mylan Institutional LLC
Morgantown, WV 26505
Manufactured by:
Mylan Institutional
Galway, Ireland
1084L101
Revised: 10/2021
MI:MAGNIJ:R4
PRINCIPAL DISPLAY PANEL - 200 mg/mL
NDC 67457-134-50 50 mL
Magnesium
Chloride
Injection
200 mg/mL
(20% w/v)
2.951 mOsm/mL
For Intravenous Use After
Dilution
Rx only Multiple-Dose Vial
Each mL contains: Magnesium
Chloride Hexahydrate 200 mg,
Sodium Chloride 9 mg, Benzyl
Alcohol 1% as a preservative,
Water for Injection q.s. pH adjusted
with Hydrochloric Acid and/or
Sodium Hydroxide.
Total osmolarity equivalent to
2.951 mOsm/mL.
Contains 1.97 mEq of Mg++ and CI¯
per mL.
WARNING: DO NOT USE IF A
PRECIPITATE IS PRESENT.
Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]
Usual Dosage: See accompanying
prescribing information.
Manufactured for:
Mylan Institutional LLC
Morgantown, WV 26505 U.S.A.
Manufactured by:
Mylan Institutional
Galway, Ireland
MI:134:1C:R5
Mylan.com
INGREDIENTS AND APPEARANCE
| MAGNESIUM CHLORIDE
magnesium chloride injection |
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| Labeler - Mylan Institutional LLC (790384502) |