Prescription drug · ANDA
Calcium Chloride (Calcium chloride injection) NDC 64253-900
Calcium chloride 100 mg/mL · Injection, Solution · Intravenous · Medefil, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64253-900-36 | 6425309003664253090036 | 60 SYRINGE, PLASTIC in 1 BOX (64253-900-36) / 10 mL in 1 SYRINGE, PLASTIC (64253-900-30)Marketed from Aug 22, 2019 | |
| 64253-900-91 | 6425309009164253090091 | 10 SYRINGE, PLASTIC in 1 BOX (64253-900-91) / 10 mL in 1 SYRINGE, PLASTICMarketed from Sep 21, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Calcium Chloride
- Generic name (nonproprietary)
- calcium chloride injection
- Active ingredients
- Calcium chloride — 100 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Medefil, Inc.NDC labeler code 64253
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211553
- Marketing start
- Listing expires
- Other FDA classes
- Calcium (Chemical structure)Divalent (Chemical structure)Increased Coagulation Factor Activity (Physiologic effect)Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 64253-900_37c737b1-dc25-bcce-e063-6294a90a6f70SPL ID 37c737b1-dc25-bcce-e063-6294a90a6f70SPL set ID 90b8936e-61f2-5318-e053-2995a90aac44RxCUI 828527UNII M4I0D6VV5M
- Pharmacologic class
- Blood Coagulation Factor; Phosphate Binder
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N464253090036followed by a unit qualifier and the quantityPackage 64253-0900-36. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
10% Calcium Chloride Injection, USP is indicated for the treatment of hypocalcemia in those conditions requiring a prompt increase in plasma calcium levels. 10% Calcium Chloride Injection, USP is indicated for the treatment of hypocalcemia in those conditions requiring a prompt increase in plasma calcium levels.
Excerpt only. Read the full label for complete information.
About NDC 64253-900
- What is NDC 64253-900?
- 64253-900 is the product NDC for Calcium Chloride (calcium chloride injection), Calcium chloride 100 mg/mL injection, solution, listed with the FDA by Medefil, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Calcium Chloride (Calcium Chloride Injection).
- What is the active ingredient?
- Calcium chloride.
- Who is the labeler?
- Medefil, Inc., NDC labeler code 64253. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Calcium Chloride?
- 20 other product NDCs are listed under this name. See all Calcium Chloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Calcium Chloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| calcium chloride | Calcium chloride 100 mg/mL | Injection, SolutionIntravenous | PAI Holdings, LLC dba PAI Pharma | 0121-1099 | 00121-1099-02 |
| calcium chloride | Calcium chloride 100 mg/mL | Injection, SolutionIntravenous | Eskayef Pharmaceuticals Limited | 72658-1879 | 72658-1879-02 |
| Calcium Chloridecalcium chloride injection | Calcium chloride 100 mg/mL | Injection, SolutionIntravenous | REMEDYREPACK INC. | 70518-4734 | 70518-4734-00 |
| calcium chloride | Calcium chloride 100 mg/mL | Injection, SolutionIntravenous | SQUARE PHARMACEUTICALS PLC. | 76483-108 | 76483-0108-02 |
| Calcium Chloride | Calcium chloride 100 mg/mL | Injection, SolutionIntravenous | Dr. Reddy's Laboratories Inc. | 75907-223 | 75907-0223-10 |
| Calcium Chloride | Calcium chloride 100 mg/mL | InjectionIntravenous, Intraventricular | REMEDYREPACK INC. | 70518-4180 | 70518-4180-00 |
| calcium chloride | Calcium chloride 100 mg/mL | Injection, SolutionIntravenous | Amneal Pharmaceuticals LLC | 70121-2308 | 70121-2308-04 |
| calcium chloride | Calcium chloride 100 mg/mL | Injection, SolutionIntravenous | Amneal Pharmaceuticals LLC | 70121-2309 | 70121-2309-07 |
| Calcium Chloride | Calcium chloride 100 mg/mL | Injection, SolutionIntravenous | Henry Schein, Inc. | 0404-9830 | 00404-9830-10 |
| Calcium Chloride | Calcium chloride 100 mg/mL | Injection, SolutionIntravenous | Civica, Inc. | 72572-052 | 72572-0052-10 |
Other NDCs under ANDA 211553
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Calcium Chloridecalcium chloride injection | Calcium chloride 100 mg/mL | Injection, SolutionIntravenous | REMEDYREPACK INC. | 70518-4734 |
| Calcium Chloridecalcium chloride injection | Calcium chloride 100 mg/mL | Injection, SolutionIntravenous | Medical Purchasing Solutions, LLC | 71872-7193 |