Calcium Gluconate NDC 65145-171

NDC codes

FDA NDC Directory

Product NDC (as listed)65145-171Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65145-0171Add 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
65145-171-25	65145017125	25 VIAL, PLASTIC in 1 CARTON (65145-171-25) / 50 mL in 1 VIAL, PLASTIC (65145-171-01)Marketed from May 13, 2026

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: Caplin Steriles Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218840
Marketing start: May 13, 2026
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 65145-171_f28e9871-d546-4b48-ac3d-aead0d4c0449SPL ID f28e9871-d546-4b48-ac3d-aead0d4c0449SPL set ID f28e9871-d546-4b48-ac3d-aead0d4c0449RxCUI 197435, 1668248, 1668250UNII CZN0MI5R31UPC 0365145171252, 0365145170019, 0365145172204, 0365145172013, 0365145171016, 0365145170255
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

N465145017125 followed by a unit qualifier and the quantity

Package 65145-0171-25. 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 May 13, 2026.

Indications (excerpt from the label)

Calcium Gluconate 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 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)

Other NDCs under ANDA 218840

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

FDA NDC Directory listings under ANDA 218840
Product	Strength	Form · route	Labeler	Product NDC
Calcium Gluconate	Calcium gluconate monohydrate 100 mg/mL	Injection, SolutionIntravenous	Caplin Steriles Limited	65145-170
Calcium Gluconate	Calcium gluconate monohydrate 100 mg/mL	Injection, SolutionIntravenous	Caplin Steriles Limited	65145-172
Calcium Gluconate	Calcium gluconate monohydrate 100 mg/mL	Injection, SolutionIntravenous	GLENMARK PHARMACEUTICALS INC., USA	68462-790
Calcium Gluconate	Calcium gluconate monohydrate 100 mg/mL	Injection, SolutionIntravenous	GLENMARK PHARMACEUTICALS INC., USA	68462-789
Calcium Gluconate	Calcium gluconate monohydrate 100 mg/mL	Injection, SolutionIntravenous	GLENMARK PHARMACEUTICALS INC., USA	68462-791