calcium gluconate
- Product NDC
- 80830-1674
- 11-digit product format
- 808301674
- Labeler code
- 80830
- Product ID
- 80830-1674_eefdd45b-6407-4e69-b285-cd5b09d8dbdd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- calcium gluconate
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Amneal Pharmaceuticals Private Limited
- Application
- ANDA216611
- Marketing category
- ANDA
- Marketing start
- 2024-05-13
- 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
- 2027-12-31
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 |
|---|
| 80830-1674-2 | calcium gluconate | 10 in 1 CARTON | INJECTION | 10 | | 3 |
| 80830-1674-5 | calcium gluconate | 25 in 1 CARTON | INJECTION | 25 | | 3 |
| 80830-1674-8 | calcium gluconate | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80830-1674 | CALCIUM GLUCONATE INJECTION [AMNEAL PHARMACEUTICALS PRIVATE LIMITED] | 3 | Current NDC, 3 package rows | 20240513_13d7cfc9-ff7a-437e-8c21-d9709ac07d48.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80830-1674-2 | 80830167402 | 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (80830-1674-2) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (80830-1674-8) | | 2024-05-13 | No | No | Historical |
| 80830-1674-5 | 80830167405 | 25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (80830-1674-5) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (80830-1674-8) | | 2024-05-13 | No | No | Historical |
| 80830-1674-8 | 80830167408 | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE | 100 ml | | | | Historical |