Doxercalciferol NDC 43598-850

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-850Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0850Add 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
43598-850-50	43598085050	50 VIAL, MULTI-DOSE in 1 CARTON (43598-850-50) / 2 mL in 1 VIAL, MULTI-DOSE (43598-850-11)Marketed from Nov 13, 2019

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): Doxercalciferol
Generic name (nonproprietary): doxercalciferol
Active ingredients: Doxercalciferol — 4 ug/2mL
Dosage form: Injection
Route: Intravenous
Labeler: Dr.Reddy's Laboratories Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210452
Marketing start: Nov 13, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Ergocalciferols (Chemical structure)
Identifiers: Product ID 43598-850_7eef9f4d-4266-ea15-9f02-978034760eb7SPL ID 7eef9f4d-4266-ea15-9f02-978034760eb7SPL set ID f472b60a-e6f5-1a87-3eff-539d6287d285RxCUI 282609UNII 3DIZ9LF5Y9
Pharmacologic class: Vitamin D2 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

N443598085050 followed by a unit qualifier and the quantity

Package 43598-0850-50. 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 Dec 20, 2024.

Indications (excerpt from the label)

Doxercalciferol Injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis. Doxercalciferol is a synthetic vitamin D 2 analog: Doxercalciferol Injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis. (1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210452

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

FDA NDC Directory listings under ANDA 210452
Product	Strength	Form · route	Labeler	Product NDC
Doxercalciferol	Doxercalciferol 4 ug/2mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-300
Doxercalciferol	Doxercalciferol 4 ug/2mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-359