Calcium Gluconate
- Product NDC
- 0404-9831
- 11-digit product format
- 004049831
- Labeler code
- 0404
- Product ID
- 0404-9831_f98230b1-9032-485d-9879-f3678c6dd4a0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Calcium Gluconate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Henry Schein, Inc.
- Application
- NDA208418
- Marketing category
- NDA
- Marketing start
- 2022-01-09
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9831-10 | Calcium Gluconate | 10 mL in 1 VIAL, PLASTIC | INJECTION, SOLUTION | 10 | | 7 |
| 0404-9831-10 | Calcium Gluconate | 1 in 1 BAG | INJECTION, SOLUTION | 1 | | 7 |
| 0404-9831-50 | Calcium Gluconate | 50 mL in 1 VIAL, PLASTIC | INJECTION, SOLUTION | 50 | | 7 |
| 0404-9831-50 | Calcium Gluconate | 1 in 1 BAG | INJECTION, SOLUTION | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9831 | CALCIUM GLUCONATE INJECTION, SOLUTION [HENRY SCHEIN, INC.] | 5 | Current NDC, Legacy NDC, 4 package rows | 20240627_841ea51f-dc0d-45ed-8b55-bb64640cb930.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0404-9831-10 | 00404983110 | 1 VIAL, PLASTIC in 1 BAG (0404-9831-10) / 10 mL in 1 VIAL, PLASTIC | 2022-01-09 | 2026-12-31 | No | No | Current |
| 0404-9831-50 | 00404983150 | 1 VIAL, PLASTIC in 1 BAG (0404-9831-50) / 50 mL in 1 VIAL, PLASTIC | 2022-01-09 | 0000-00-00 | No | No | Current |