Calcium Gluconate
- Product NDC
- 0264-5600
- 11-digit product format
- 002645600
- Labeler code
- 0264
- Product ID
- 0264-5600_c39effaa-a9b8-4430-a42a-c642b76550df
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Calcium Gluconate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- B. Braun Medical Inc.
- Application
- ANDA216541
- Marketing category
- ANDA
- Marketing start
- 2023-11-02
- 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 |
|---|
| 0264-5600-52 | Calcium Gluconate | 100 mL in 1 CONTAINER | INJECTION, SOLUTION | 100 | | 5 |
| 0264-5600-52 | Calcium Gluconate | 24 in 1 CASE | INJECTION, SOLUTION | 24 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0264-5600 | CALCIUM GLUCONATE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.] | 5 | Current NDC, 2 package rows | 20231104_af362bcb-7010-4eb5-b8c4-42aa3b0cdcde.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0264-5600-52 | 00264560052 | 24 CONTAINER in 1 CASE (0264-5600-52) / 100 mL in 1 CONTAINER | 24 container | 2023-11-02 | No | No | Current |