Prescription drug · ANDA
Desmopressin Acetate NDC 51655-461
Desmopressin acetate .2 mg/1 · Tablet · Oral · Northwind Health Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51655-461-52 | 5165504615251655046152 | 30 TABLET in 1 BOTTLE, PLASTIC (51655-461-52)Marketed from Oct 29, 2020 |
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
- Northwind Health Company, LLCNDC labeler code 51655
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210371
- Marketing start
- Listing expires
- Other FDA classes
- Increased Coagulation Factor VIII Activity (Physiologic effect)Increased Coagulation Factor VIII Concentration (Physiologic effect)Vasopressins (Chemical structure)
- Identifiers
- Product ID 51655-461_490efdbc-280a-2644-e063-6294a90a583dSPL ID 490efdbc-280a-2644-e063-6294a90a583dSPL set ID f306e2d4-781f-ff8f-e053-2a95a90ad15bRxCUI 833008UNII XB13HYU18U
- 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
N451655046152followed by a unit qualifier and the quantityPackage 51655-0461-52. 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 .
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.
About NDC 51655-461
- What is NDC 51655-461?
- 51655-461 is the product NDC for Desmopressin Acetate, Desmopressin acetate .2 mg/1 tablet, listed with the FDA by Northwind Health Company, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Desmopressin Acetate.
- What is the active ingredient?
- Desmopressin acetate.
- Who is the labeler?
- Northwind Health Company, LLC, NDC labeler code 51655. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Desmopressin Acetate?
- 48 other product NDCs are listed under this name. See all Desmopressin Acetate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Desmopressin Acetate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Desmopressin Acetate | Desmopressin acetate 4 ug/mL | Injection, SolutionIntravenous, Subcutaneous | The J. Molner Company LLC | 83148-126 | 83148-0126-01 |
| Desmopressin Acetate | Desmopressin acetate 4 ug/mL | Injection, SolutionIntravenous, Subcutaneous | Armas Pharmaceuticals Inc. | 72485-523 | 72485-0523-10 |
| Desmopressin Acetate | Desmopressin acetate 40 ug/10mL | Injection, SolutionIntravenous, Subcutaneous | Armas Pharmaceuticals Inc. | 72485-524 | 72485-0524-01 |
| Desmopressin Acetate | Desmopressin acetate .1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4612 | 70518-4612-00 |
| Desmopressin Acetate | Desmopressin acetate 4 ug/mL | Injection, SolutionIntravenous | Caplin Steriles Limited | 65145-183 | 65145-0183-10 |
| Desmopressin Acetate | Desmopressin acetate 4 ug/mL | Injection, SolutionIntravenous | Caplin Steriles Limited | 65145-184 | 65145-0184-01 |
| Desmopressin acetate | Desmopressin acetate 4 ug/mL | InjectionIntravenous, Subcutaneous | Meitheal Pharmaceuticals Inc. | 71288-440 | 71288-0440-02 |
| Desmopressin acetate | Desmopressin acetate 4 ug/mL | InjectionIntravenous, Subcutaneous | Meitheal Pharmaceuticals Inc. | 71288-441 | 71288-0441-10 |
| Desmopressin Acetate | Desmopressin acetate .1 mg/mL | SolutionNasal | Oceanside Pharmaceuticals | 68682-342 | 68682-0342-05 |
| Desmopressin Acetate | Desmopressin acetate 4 ug/mL | Injection, SolutionIntravenous, Subcutaneous | XGen Pharmaceuticals DJB, Inc. | 39822-6200 | 39822-6200-02 |
Other NDCs under ANDA 210371
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Desmopressin Acetate | Desmopressin acetate .1 mg/1 | TabletOral | KVK-TECH, INC. | 10702-169 |
| Desmopressin Acetate | Desmopressin acetate .2 mg/1 | TabletOral | KVK-TECH, INC. | 10702-170 |