Desmopressin Acetate NDC 68462-276

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-276Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0276Add 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
68462-276-01	68462027601	100 TABLET in 1 BOTTLE (68462-276-01)Marketed from May 28, 2015
68462-276-10	68462027610	1000 TABLET in 1 BOTTLE (68462-276-10)Marketed from May 28, 2015
68462-276-30	68462027630	30 TABLET in 1 BOTTLE (68462-276-30)Marketed from May 28, 2015
68462-276-90	68462027690	90 TABLET in 1 BOTTLE (68462-276-90)Marketed from May 28, 2015

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: Glenmark Pharmaceuticals Inc.,USA
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201831
Marketing start: May 28, 2015
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 68462-276_d9414e03-41d5-4e96-9ce6-b298c365281dSPL ID d9414e03-41d5-4e96-9ce6-b298c365281dSPL set ID 7a26b415-77cd-4b2f-9c76-fa52d2eb6be6RxCUI 833008, 849515UNII XB13HYU18UUPC 0368462276013, 0368462275016
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

N468462027601 followed by a unit qualifier and the quantity

Package 68462-0276-01. 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 Jun 28, 2019.

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 tablets are 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 Enuresi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 201831

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

FDA NDC Directory listings under ANDA 201831
Product	Strength	Form · route	Labeler	Product NDC
Desmopressin Acetate	Desmopressin acetate .1 mg/1	TabletOral	Glenmark Pharmaceuticals Inc.,USA	68462-275