Desmopressin Acetate NDC 68001-575

NDC codes

FDA NDC Directory

Product NDC (as listed)68001-575Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68001-0575Add 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
68001-575-00	68001057500	100 TABLET in 1 BOTTLE (68001-575-00)Marketed from Aug 3, 2023

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): Desmopressin Acetate
Generic name (nonproprietary): desmopressin acetate
Active ingredients: Desmopressin acetate — .2 mg/1
Dosage form: Tablet
Route: Oral
Labeler: BluePoint Laboratories
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077414
Marketing start: Aug 3, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Increased Coagulation Factor VIII Activity (Physiologic effect)Increased Coagulation Factor VIII Concentration (Physiologic effect)Vasopressins (Chemical structure)
Identifiers: Product ID 68001-575_02150d95-2c55-cd5b-e063-6394a90aafadSPL ID 02150d95-2c55-cd5b-e063-6394a90aafadSPL set ID c04357fd-478a-4909-b098-ae6710be071cRxCUI 833008, 849515UNII XB13HYU18UUPC 0368001574006, 0368001575003
Pharmacologic class: Factor VIII Activator; Vasopressin 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

N468001057500 followed by a unit qualifier and the quantity

Package 68001-0575-00. 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 4, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Central Diabetes Insipidus Desmopressin acetate tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Desmopressin acetate is ineffective for the treatment of nephrogenic diabetes insipidus. Patients were selected for therapy based on the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or response to antidiuretic hormone. Continued response to desmopressin acetate can be monitored by measuring urine volume and osmolality. Primary Nocturnal Enuresis Desmopre…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077414

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

FDA NDC Directory listings under ANDA 077414
Product	Strength	Form · route	Labeler	Product NDC
Desmopressin Acetate	Desmopressin acetate .2 mg/1	TabletOral	Apotex Corp.	60505-0258
Desmopressin Acetate	Desmopressin acetate trihydrate .1 mg/1	TabletOral	Apotex Corp.	60505-0257
Desmopressin Acetate	Desmopressin acetate .2 mg/1	TabletOral	Bryant Ranch Prepack	63629-3257
Desmopressin Acetate	Desmopressin acetate .1 mg/1	TabletOral	BluePoint Laboratories	68001-574
Desmopressin Acetate	Desmopressin acetate .1 mg/1	TabletOral	American Health Packaging	60687-721
Desmopressin Acetate	Desmopressin acetate .2 mg/1	TabletOral	American Health Packaging	60687-732