Cardioplegic
- Product NDC
- 0338-0341
- 11-digit product format
- 003380341
- Labeler code
- 0338
- Product ID
- 0338-0341_f82c5f8a-ad36-4053-94e5-ec06322f9991
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Calcium Chloride, Magnesium Chloride, Potassium Chloride and Sodium Chloride
- Dosage form
- SOLUTION
- Route
- INTRA-ARTERIAL
- Labeler
- Baxter Healthcare Corporation
- Application
- ANDA075323
- Marketing category
- ANDA
- Marketing start
- 2000-04-21
- 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], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cardioplegic
- Listing expiration
- 2027-12-31
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#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0338-0341-04 | 2021-08-03 | C162847 | 48780-1 | c7ccaba7-1b45-fd44-e053-dadaa90aa01b | CARDIOPLEGIC SOLUTION |
| 0338-0341-04 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-1b45-fd44-e053-dadaa90aa01b | CARDIOPLEGIC SOLUTION |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0338-0341-04 | Cardioplegic | 14 in 1 CARTON | SOLUTION | 14 | 13 | |
| 0338-0341-04 | Cardioplegic | 1000 mL in 1 BAG | SOLUTION | 1000 | 13 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0338-0341-04 | ML - Milliliter | 0338-0341 | b13da35d-cc70-4588-bf4a-940eb9db57a6 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0338-0341 | CARDIOPLEGIC (CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM CHLORIDE) SOLUTION [BAXTER HEALTHCARE CORPORATION] | 12 | Current NDC, Legacy NDC, 2 package rows | 20250214_1fd50ce5-2799-4c26-81da-02cf0578dd9e.zip |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0338-0341-04 | 00338034104 | 14 BAG in 1 CARTON (0338-0341-04) / 1000 mL in 1 BAG | 14 bag | 2000-04-21 | 0000-00-00 | No | No | Current |