Cardioplegic Solution
- Product NDC
- 65219-258
- 11-digit product format
- 652190258
- Labeler code
- 65219
- Product ID
- 65219-258_9c1af4dc-3653-49cb-baa5-e916369a4e0a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, and MAGNESIUM CHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRA-ARTERIAL
- Labeler
- Fresenius Kabi, USA, LLC
- Application
- ANDA214623
- Marketing category
- ANDA
- Marketing start
- 2022-06-06
- Substance
- CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
- Active strength
- 17.6; 325.3; 119.3; 643 mg/100mL; mg/100mL; mg/100mL; mg/100mL
- Pharmacologic classes
- Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cardioplegic Solution
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CALCIUM CHLORIDE | 17.6 mg/100mL |
| MAGNESIUM CHLORIDE | 325.3 mg/100mL |
| POTASSIUM CHLORIDE | 119.3 mg/100mL |
| SODIUM CHLORIDE | 643 mg/100mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | M4I0D6VV5M, 02F3473H9O, 660YQ98I10, 451W47IQ8X |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65219-258-01 | Cardioplegic Solution | 1000 mL in 1 BAG | INJECTION, SOLUTION | 1000 | 4 | |
| 65219-258-10 | Cardioplegic Solution | 10 in 1 CASE | INJECTION, SOLUTION | 10 | 4 | |
| 65219-258-10 | Cardioplegic Solution | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65219-258-01 | ML - Milliliter | 65219-258 | 1a70cebb-a2a2-4fc7-aba7-e3d33dc3ee0a | 1 | 2023-06-06 |
| 65219-258-10 | ML - Milliliter | 65219-258 | 6f993564-0dbf-4777-a20d-6b46dfd7b2c6 | 1 | 2023-06-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 65219-258 | CARDIOPLEGIC SOLUTION (POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI, USA, LLC] | 4 | Current NDC, Legacy NDC, 3 package rows | 20220606_eb360dc4-88d6-4b28-9b61-bc359e16bd22.zip |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65219-258-01 | 65219025801 | 1000 mL in 1 BAG | 1000 ml | Historical | ||||
| 65219-258-10 | 65219025810 | 10 POUCH in 1 CASE (65219-258-10) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG (65219-258-01) | 10 pouch | 2022-06-06 | 0000-00-00 | No | No | Current |