calcium gluconate
- Product NDC
- 0143-9185
- 11-digit product format
- 001439185
- Labeler code
- 0143
- Product ID
- 0143-9185_8ec4d137-1e9b-40e2-aeb2-8f62626a8fa5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- calcium gluconate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA213071
- Marketing category
- ANDA
- Marketing start
- 2024-06-30
- 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 | 197435 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0143-9185-01 | calcium gluconate | 100 mL in 1 VIAL | INJECTION, SOLUTION | 100 | | 1 |
| 0143-9185-20 | calcium gluconate | 20 in 1 CARTON | INJECTION, SOLUTION | 20 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9185 | CALCIUM GLUCONATE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 1 | Current NDC, 2 package rows | 20240630_8ec4d137-1e9b-40e2-aeb2-8f62626a8fa5.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 |
|---|
| 0143-9185-01 | 00143918501 | 100 mL in 1 VIAL | 100 ml | | | | Historical |
| 0143-9185-20 | 00143918520 | 20 VIAL in 1 CARTON (0143-9185-20) / 100 mL in 1 VIAL (0143-9185-01) | 20 vial | 2024-06-30 | No | No | Historical |