Calcitriol NDC 0093-7353

NDC codes

FDA NDC Directory

Product NDC (as listed)0093-7353Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00093-7353Add 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
0093-7353-01	00093735301	100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0093-7353-01)Marketed from Jul 1, 2016

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — .5 ug/1
Dosage form: Capsule, Liquid filled
Route: Oral
Labeler: Teva Pharmaceuticals USA, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075765
Marketing start: Jul 1, 2016
Marketing end: Feb 28, 2027
Other FDA classes: Cholecalciferol (Chemical structure)
Identifiers: Product ID 0093-7353_9e6df585-e3d1-4a89-bc02-8e4b223578c4SPL ID 9e6df585-e3d1-4a89-bc02-8e4b223578c4SPL set ID ec93b667-aad2-4e3a-adc6-952f070a0c0aRxCUI 308867, 308868UNII FXC9231JVHUPC 0300937353010, 0300937352013
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400093735301 followed by a unit qualifier and the quantity

Package 00093-7353-01. 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 Aug 1, 2019.

Indications (excerpt from the label)

INDICATIONS AND USAGE Predialysis Patients Calcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (C cr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism. Dialysis Patients Calcitriol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol administration enhances calcium absorption, reduces se…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075765

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

FDA NDC Directory listings under ANDA 075765
Product	Strength	Form · route	Labeler	Product NDC
Calcitriol	Calcitriol .5 ug/1	Capsule, Liquid filledOral	Bryant Ranch Prepack	63629-8742
Calcitriol	Calcitriol .25 ug/1	Capsule, Liquid filledOral	Bryant Ranch Prepack	63629-8741
Calcitriol	Calcitriol .25 ug/1	Capsule, Liquid filledOral	Teva Pharmaceuticals USA, Inc.	0093-7352
Calcitriol	Calcitriol .25 ug/1	Capsule, Liquid filledOral	Bryant Ranch Prepack	72162-1031
Calcitriol	Calcitriol .5 ug/1	Capsule, Liquid filledOral	Bryant Ranch Prepack	71335-1594