Calcium Chloride
- Product NDC
- 64253-900
- 11-digit product format
- 642530900
- Labeler code
- 64253
- Product ID
- 64253-900_37c737b1-dc25-bcce-e063-6294a90a6f70
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Calcium Chloride Injection
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Medefil, Inc.
- Application
- ANDA211553
- Marketing category
- ANDA
- Marketing start
- 2019-08-22
- Substance
- CALCIUM CHLORIDE
- Active strength
- 100 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 Chloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CALCIUM CHLORIDE | 100 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | M4I0D6VV5M |
| Rxcui | 828527 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 64253-900-36 | 2022-06-27 | C162847 | 48780-1 | d6a99b39-955e-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use 10% CALCIUM CHLORIDE INJECTION, USP safely and effectively. See full prescribing information for 10% CALCIUM CHLORIDE INJECTION, USP. 10% CALCIUM CHLORIDE INJECTION, USP for Intravenous Injection Initial U.S. Approval: 2019 |
| 64253-900-91 | 2022-06-27 | C162847 | 48780-1 | d6a99b39-955e-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use 10% CALCIUM CHLORIDE INJECTION, USP safely and effectively. See full prescribing information for 10% CALCIUM CHLORIDE INJECTION, USP. 10% CALCIUM CHLORIDE INJECTION, USP for Intravenous Injection Initial U.S. Approval: 2019 |
| 64253-900-36 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-955e-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use 10% CALCIUM CHLORIDE INJECTION, USP safely and effectively. See full prescribing information for 10% CALCIUM CHLORIDE INJECTION, USP. 10% CALCIUM CHLORIDE INJECTION, USP for Intravenous Injection Initial U.S. Approval: 2019 |
| 64253-900-91 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-955e-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use 10% CALCIUM CHLORIDE INJECTION, USP safely and effectively. See full prescribing information for 10% CALCIUM CHLORIDE INJECTION, USP. 10% CALCIUM CHLORIDE INJECTION, USP for Intravenous Injection Initial U.S. Approval: 2019 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64253-900-30 | Calcium Chloride | 10 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 10 | | 5 |
| 64253-900-36 | Calcium Chloride | 60 in 1 BOX | INJECTION, SOLUTION | 60 | | 5 |
| 64253-900-91 | Calcium Chloride | 10 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 10 | | 5 |
| 64253-900-91 | Calcium Chloride | 10 in 1 BOX | INJECTION, SOLUTION | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64253-900 | CALCIUM CHLORIDE (CALCIUM CHLORIDE INJECTION) INJECTION, SOLUTION [MEDEFIL, INC.] | 4 | Current NDC, Legacy NDC, 4 package rows | 20230615_90b8936e-61f2-5318-e053-2995a90aac44.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 64253-900-30 | 64253090030 | 10 mL in 1 SYRINGE, PLASTIC | 10 ml | | | | | Historical |
| 64253-900-36 | 64253090036 | 60 SYRINGE, PLASTIC in 1 BOX (64253-900-36) / 10 mL in 1 SYRINGE, PLASTIC (64253-900-30) | | 2019-08-22 | 0000-00-00 | No | No | Current |
| 64253-900-91 | 64253090091 | 10 SYRINGE, PLASTIC in 1 BOX (64253-900-91) / 10 mL in 1 SYRINGE, PLASTIC | | 2020-09-21 | 0000-00-00 | No | No | Current |