What is NDC 80830-2363?

80830-2363 is the product NDC for Calcium Gluconate, Calcium gluconate monohydrate 20 mg/mL injection, solution, listed with the FDA by Amneal Pharmaceuticals Private Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals Private Limited, NDC labeler code 80830. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Calcium Gluconate NDC 80830-2363 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80830-2363Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80830-2363Add 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 NDC	11-digit (billing)	Package	Copy
80830-2363-2	8083023630280830236302	12 POUCH in 1 CARTON (80830-2363-2) / 1 BAG in 1 POUCH / 100 mL in 1 BAGMarketed from Nov 8, 2023
80830-2363-9	8083023630980830236309	24 POUCH in 1 CARTON (80830-2363-9) / 1 BAG in 1 POUCH / 100 mL in 1 BAGMarketed from Sep 8, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 20 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Amneal Pharmaceuticals Private LimitedNDC labeler code 80830
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217174
Marketing start: Sep 8, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Calcium (Chemical structure)Divalent (Chemical structure)Increased Coagulation Factor Activity (Physiologic effect)Phosphate Chelating Activity (Mechanism)
Identifiers: Product ID 80830-2363_2bd614b6-02ce-49e3-86e2-dfaec7a13e04SPL ID 2bd614b6-02ce-49e3-86e2-dfaec7a13e04SPL set ID 8ee79b4c-21d3-4742-ae37-e2f562917706RxCUI 2117608, 2117610UNII CZN0MI5R31UPC 0380830236290
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

N480830236302 followed by a unit qualifier and the quantity

Package 80830-2363-02. 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 Apr 18, 2024.

Indications (excerpt from the label)

Calcium gluconate in sodium chloride injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Limitations of Use The safety of calcium gluconate injection for long term use has not been established. Calcium gluconate in sodium chloride 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 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80830-2363

What is NDC 80830-2363?: 80830-2363 is the product NDC for Calcium Gluconate, Calcium gluconate monohydrate 20 mg/mL injection, solution, listed with the FDA by Amneal Pharmaceuticals Private Limited. It has 2 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?: Amneal Pharmaceuticals Private Limited, NDC labeler code 80830. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Calcium Gluconate	Calcium gluconate monohydrate 100 mg/mL	Injection, SolutionIntravenous	Caplin Steriles Limited	65145-170	65145-0170-25
Calcium Gluconate	Calcium gluconate monohydrate 100 mg/mL	Injection, SolutionIntravenous	Caplin Steriles Limited	65145-171	65145-0171-25
Calcium Gluconate	Calcium gluconate monohydrate 100 mg/mL	Injection, SolutionIntravenous	Caplin Steriles Limited	65145-172	65145-0172-20
Calcium Gluconate	Calcium gluconate monohydrate 100 mg/mL	Injection, SolutionIntravenous	GLENMARK PHARMACEUTICALS INC., USA	68462-789	68462-0789-25
Calcium Gluconate	Calcium gluconate monohydrate 100 mg/mL	Injection, SolutionIntravenous	GLENMARK PHARMACEUTICALS INC., USA	68462-790	68462-0790-25
Calcium Gluconate	Calcium gluconate monohydrate 100 mg/mL	Injection, SolutionIntravenous	GLENMARK PHARMACEUTICALS INC., USA	68462-791	68462-0791-20
calcium gluconate	Calcium gluconate monohydrate 98 mg/mL	Injection, SolutionIntravenous	Amneal Pharmaceuticals Private Limited	80830-1672	80830-1672-04
Calcium Gluconate	Calcium gluconate monohydrate 98 mg/mL	Injection, SolutionIntravenous	Henry Schein, Inc.	0404-9764	00404-9764-10
calcium gluconate	Calcium gluconate monohydrate 98 mg/mL	Injection, SolutionIntravenous	REMEDYREPACK INC.	70518-4355	70518-4355-00
Calcium Gluconate	Calcium gluconate monohydrate 98 mg/mL	Injection, SolutionIntravenous	REMEDYREPACK INC.	70518-4178	70518-4178-00

All 30 Calcium Gluconate NDCs

Other NDCs under ANDA 217174

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

FDA NDC Directory listings under ANDA 217174
Product	Strength	Form · route	Labeler	Product NDC
Calcium Gluconate	Calcium gluconate monohydrate 20 mg/mL	Injection, SolutionIntravenous	Amneal Pharmaceuticals Private Limited	80830-2362