Calcium Gluconate
- Product NDC
- 65219-630
- 11-digit product format
- 652190630
- Labeler code
- 65219
- Product ID
- 65219-630_166681fc-9f43-470d-81e2-ff8be7cd39dc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Calcium Gluconate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- NDA208418
- Marketing category
- NDA
- Marketing start
- 2017-06-15
- Substance
- CALCIUM GLUCONATE MONOHYDRATE
- Active strength
- 98 mg/mL
- Pharmacologic classes
- Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Calcium Gluconate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CALCIUM GLUCONATE MONOHYDRATE | 98 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CZN0MI5R31 |
| Rxcui | 1668250 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65219-630-01 | Calcium Gluconate | 10 mL in 1 VIAL, PLASTIC | INJECTION, SOLUTION | 10 | | 1 |
| 65219-630-19 | Calcium Gluconate | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65219-630 | CALCIUM GLUCONATE (CALCIUM GLUCONATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | Current NDC, 2 package rows | 20240905_1aaf5c76-e526-4d8b-887e-cc3c4f39cc8b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65219-630-01 | 65219063001 | 10 mL in 1 VIAL, PLASTIC | 10 ml | | | | Historical |
| 65219-630-19 | 65219063019 | 25 VIAL, PLASTIC in 1 TRAY (65219-630-19) / 10 mL in 1 VIAL, PLASTIC (65219-630-01) | | 2017-06-15 | No | No | Current |