What is NDC 45802-608?

45802-608 is the product NDC for calcitriol, Calcitriol 3 ug/g ointment, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.

Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. 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 45802-608 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-608Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0608Add 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
45802-608-01	4580206080145802060801	1 TUBE in 1 CARTON (45802-608-01) / 100 g in 1 TUBEMarketed from Mar 8, 2012

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 — 3 ug/g
Dosage form: Ointment
Route: Topical
Labeler: Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 022087
Marketing start: Mar 8, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Cholecalciferol (Chemical structure)
Identifiers: Product ID 45802-608_d1600f2d-9c61-486e-9ef0-54160ef6adc3SPL ID d1600f2d-9c61-486e-9ef0-54160ef6adc3SPL set ID 7fa4ab07-3d8e-4300-91f3-b1e17cba8691RxCUI 388517UNII 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 HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N445802060801 followed by a unit qualifier and the quantity

Package 45802-0608-01. 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 Jan 31, 2023.

Indications (excerpt from the label)

Calcitriol Ointment is a vitamin D analog indicated for the topical treatment of mild to moderate plaque psoriasis in adults and pediatric patients 2 years and older ( 1.1 ) Limitations of Use The safety and effectiveness of Calcitriol Ointment in patients with known or suspected disorders of calcium metabolism have not been evaluated. ( 1.2 ) 1.1 Indication Calcitriol Ointment is indicated for the topical treatment of mild to moderate plaque psoriasis in adults and pediatric patients 2 years and older. 1.2 Limitations of Use The safety and effectiveness of Calcitriol Ointment in patients with known or suspected disorders of calcium metabolism have not been evaluated.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 45802-608

What is NDC 45802-608?: 45802-608 is the product NDC for calcitriol, Calcitriol 3 ug/g ointment, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. 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?: Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. 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
Calcitriol	Calcitriol 1 ug/mL	InjectionIntravenous	Gland Pharma Limited	68083-316	68083-0316-10
Calcitriolcalcitriol capsules 0.25 mcg	Calcitriol .25 ug/1	CapsuleOral	Cardinal Health 107, LLC	55154-8186	55154-8186-00

All 40 calcitriol NDCs

Other NDCs under NDA 022087

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

FDA NDC Directory listings under NDA 022087
Product	Strength	Form · route	Labeler	Product NDC
Vecticalcalcitriol	Calcitriol 3 ug/g	OintmentTopical	Galderma Laboratories, L.P.	0299-2012