Plegisol
- Product NDC
- 0409-7969
- 11-digit product format
- 004097969
- Labeler code
- 0409
- Product ID
- 0409-7969_8e23a3f9-6a8a-4457-b8d1-e6041dfa5d25
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, and MAGNESIUM CHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRA-ARTERIAL
- Labeler
- Hospira, Inc.
- Application
- NDA018608
- Marketing category
- NDA
- Marketing start
- 2005-07-28
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Plegisol
- 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#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0409-7969-05 | Plegisol | 12 in 1 CASE | INJECTION, SOLUTION | 12 | 23 | |
| 0409-7969-05 | Plegisol | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | 23 | |
| 0409-7969-11 | Plegisol | 1000 mL in 1 BAG | INJECTION, SOLUTION | 1000 | 23 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0409-7969-05 | ML - Milliliter | 0409-7969 | a75259d7-def4-4788-bf11-f6eff6d46f42 | 1 | 2012-07-24 |
| 0409-7969-11 | ML - Milliliter | 0409-7969 | fc7ab54d-f372-4dce-9915-f5b31c351607 | 1 | 2021-02-05 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0409-7969 | PLEGISOL (POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.] | 22 | Current NDC, Legacy NDC, 3 package rows | 20240316_35a174f0-f0d7-4ec7-3f81-d3d572c059cf.zip |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0409-7969-05 | 00409796905 | 12 POUCH in 1 CASE (0409-7969-05) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG (0409-7969-11) | 12 pouch | 2005-07-28 | 0000-00-00 | No | No | Current |
| 0409-7969-11 | 00409796911 | 1000 mL in 1 BAG | 1000 ml | Historical |