What is NDC 68083-316?

68083-316 is the product NDC for Calcitriol, Calcitriol 1 ug/mL injection, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Calcitriol?

39 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Calcitriol NDC 68083-316 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-316Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0316Add 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
68083-316-10	6808303161068083031610	10 VIAL in 1 CARTON (68083-316-10) / 1 mL in 1 VIALMarketed from Feb 3, 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): Calcitriol
Generic name (nonproprietary): calcitriol
Active ingredients: Calcitriol — 1 ug/mL
Dosage form: Injection
Route: Intravenous
Labeler: Gland Pharma LimitedNDC labeler code 68083
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211030
Marketing start: Feb 3, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Cholecalciferol (Chemical structure)
Identifiers: Product ID 68083-316_7e6d4205-3332-4f96-b258-8ffde9119ed4SPL ID 7e6d4205-3332-4f96-b258-8ffde9119ed4SPL set ID d9ba544c-6ca8-410d-a306-51482a8c6848RxCUI 308869UNII FXC9231JVH
Pharmacologic class: Vitamin D3 Analog

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

N468083031610 followed by a unit qualifier and the quantity

Package 68083-0316-10. 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 Oct 10, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE Calcitriol injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68083-316

What is NDC 68083-316?: 68083-316 is the product NDC for Calcitriol, Calcitriol 1 ug/mL injection, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Calcitriol.
What is the active ingredient?: Calcitriol.
Who is the labeler?: Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Calcitriol?: 39 other product NDCs are listed under this name. See all Calcitriol 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 Calcitriol NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Calcitriol	Calcitriol 1 ug/mL	SolutionOral	ANI Pharmaceuticals, Inc.	70954-831	70954-0831-10
Calcitriol	Calcitriol .25 ug/1	CapsuleOral	EPIC PHARMA LLC	42806-732	42806-0732-01
Calcitriol	Calcitriol .5 ug/1	CapsuleOral	EPIC PHARMA LLC	42806-733	42806-0733-01
Calcitriol	Calcitriol .25 ug/1	Capsule, Liquid filledOral	Bryant Ranch Prepack	72162-1031	72162-1031-01
Calcitriol	Calcitriol 1 ug/mL	SolutionOral	Patrin Pharma, Inc	39328-042	39328-0042-15
Calcitriol	Calcitriol 1 ug/mL	InjectionIntravenous	FOSUN PHARMA USA INC	72266-251	72266-0251-10
Calcitriol	Calcitriol .25 ug/1	Capsule, Liquid filledOral	Sun Pharmaceutical Industries, Inc.	62756-967	62756-0967-1862756-0967-8362756-0967-88
Calcitriol	Calcitriol .5 ug/1	Capsule, Liquid filledOral	Sun Pharmaceutical Industries, Inc.	62756-968	62756-0968-1862756-0968-8362756-0968-88
Calcitriolcalcitriol capsules 0.25 mcg	Calcitriol .25 ug/1	CapsuleOral	Cardinal Health 107, LLC	55154-8186	55154-8186-00
Calcitriolcalcitriol capsules 0.25 mcg	Calcitriol .25 ug/1	CapsuleOral	American Health Packaging	60687-345	60687-0345-01

All 40 Calcitriol NDCs

Other NDCs under ANDA 211030

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

FDA NDC Directory listings under ANDA 211030
Product	Strength	Form · route	Labeler	Product NDC
Calcitriol	Calcitriol 1 ug/mL	InjectionIntravenous	FOSUN PHARMA USA INC	72266-251