Prescription drug · NDA

Calcium Gluconate NDC 63323-360

Calcium gluconate monohydrate 100 mg/mL · Injection, Solution · Intravenous · Fresenius Kabi USA, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)63323-360Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63323-0360Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
63323-360-19633230360196332303601925 VIAL, PLASTIC in 1 TRAY (63323-360-19) / 10 mL in 1 VIAL, PLASTIC (63323-360-01)Marketed from Jun 15, 2017
63323-360-59633230360596332303605925 VIAL, PLASTIC in 1 TRAY (63323-360-59) / 50 mL in 1 VIAL, PLASTIC (63323-360-03)Marketed from Jun 15, 2017
63323-360-61633230360616332303606120 VIAL, PLASTIC in 1 TRAY (63323-360-61) / 100 mL in 1 VIAL, PLASTIC (63323-360-05)Marketed from Jun 15, 2017

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 Gluconate
Generic name (nonproprietary)
calcium gluconate
Active ingredients
Calcium gluconate monohydrate — 100 mg/mL
Dosage form
Injection, Solution
Route
Intravenous
Labeler
Fresenius Kabi USA, LLCNDC labeler code 63323
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 208418
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 63323-360_661fc3fe-30e4-4d3e-a7a0-7405bfabe79fSPL ID 661fc3fe-30e4-4d3e-a7a0-7405bfabe79fSPL set ID 8b77c3d2-992d-4261-8421-9cfd07328fbfRxCUI 197435, 1668248, 1668250UNII CZN0MI5R31UPC 0363323360030, 0363323360054, 0363323360016
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.

How CPT relates to drug billing

NDC on a medical claim

N463323036019 followed by a unit qualifier and the quantity

Package 63323-0360-19. 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)

Calcium Gluconate Injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Calcium Gluconate Injection is a form of calcium indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. ( 1 ) Limitations of Use: The safety of Calcium Gluconate Injection for long term use has not been established. ( 1 ) Limitations of Use The safety of Calcium Gluconate Injection for long term use has not been established.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63323-360

What is NDC 63323-360?
63323-360 is the product NDC for Calcium Gluconate, Calcium gluconate monohydrate 100 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Calcium Gluconate.
What is the active ingredient?
Calcium gluconate monohydrate.
Who is the labeler?
Fresenius Kabi USA, LLC, NDC labeler code 63323. 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 Gluconate?
29 other product NDCs are listed under this name. See all Calcium Gluconate NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Calcium Gluconate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Calcium GluconateCalcium gluconate monohydrate 100 mg/mLInjection, SolutionIntravenousCaplin Steriles Limited65145-17065145-0170-25
Calcium GluconateCalcium gluconate monohydrate 100 mg/mLInjection, SolutionIntravenousCaplin Steriles Limited65145-17165145-0171-25
Calcium GluconateCalcium gluconate monohydrate 100 mg/mLInjection, SolutionIntravenousCaplin Steriles Limited65145-17265145-0172-20
Calcium GluconateCalcium gluconate monohydrate 100 mg/mLInjection, SolutionIntravenousGLENMARK PHARMACEUTICALS INC., USA68462-78968462-0789-25
Calcium GluconateCalcium gluconate monohydrate 100 mg/mLInjection, SolutionIntravenousGLENMARK PHARMACEUTICALS INC., USA68462-79068462-0790-25
Calcium GluconateCalcium gluconate monohydrate 100 mg/mLInjection, SolutionIntravenousGLENMARK PHARMACEUTICALS INC., USA68462-79168462-0791-20
calcium gluconateCalcium gluconate monohydrate 98 mg/mLInjection, SolutionIntravenousAmneal Pharmaceuticals Private Limited80830-167280830-1672-04
Calcium GluconateCalcium gluconate monohydrate 98 mg/mLInjection, SolutionIntravenousHenry Schein, Inc.0404-976400404-9764-10
calcium gluconateCalcium gluconate monohydrate 98 mg/mLInjection, SolutionIntravenousREMEDYREPACK INC.70518-435570518-4355-00
Calcium GluconateCalcium gluconate monohydrate 98 mg/mLInjection, SolutionIntravenousREMEDYREPACK INC.70518-417870518-4178-00

All 30 Calcium Gluconate NDCs

Other NDCs under NDA 208418

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 208418
ProductStrengthForm · routeLabelerProduct NDC
Calcium GluconateCalcium gluconate monohydrate 98 mg/mLInjection, SolutionIntravenousHenry Schein, Inc.0404-9831
Calcium GluconateCalcium gluconate monohydrate 98 mg/mLInjection, SolutionIntravenousHF Acquisition Co LLC, DBA HealthFirst51662-1312
Calcium GluconateCalcium gluconate monohydrate 98 mg/mLInjection, SolutionIntravenousHF Acquisition Co LLC, DBA HealthFirst51662-1347
Calcium GluconateCalcium gluconate monohydrate 20 mg/mLInjection, SolutionIntravenousFresenius Kabi USA, LLC65219-162
Calcium GluconateCalcium gluconate monohydrate 20 mg/mLInjection, SolutionIntravenousFresenius Kabi USA, LLC65219-164
Calcium GluconateCalcium gluconate monohydrate 98 mg/mLInjection, SolutionIntravenousFresenius Kabi USA, LLC65219-630
Calcium GluconateCalcium gluconate monohydrate 98 mg/mLInjection, SolutionIntravenousREMEDYREPACK INC.70518-4178
Calcium GluconateCalcium gluconate monohydrate 98 mg/mLInjection, SolutionIntravenousMedical Purchasing Solutions, LLC71872-7222
Calcium GluconateCalcium gluconate monohydrate 98 mg/mLInjection, SolutionIntravenousProPharma Distribution84549-360

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