Prescription drug · ANDA
Desmopressin Acetate NDC 59651-250
Desmopressin acetate .2 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-250-01 | 59651025001 | 100 TABLET in 1 BOTTLE (59651-250-01)Marketed from Mar 21, 2024 |
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
- Aurobindo Pharma LimitedNDC labeler code 59651
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213095
- 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 59651-250_24866ad0-94db-46a2-96c0-b362acd0271aSPL ID 24866ad0-94db-46a2-96c0-b362acd0271aSPL set ID 24866ad0-94db-46a2-96c0-b362acd0271aRxCUI 833008, 849515UNII 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
N459651025001followed by a unit qualifier and the quantityPackage 59651-0250-01. 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 .
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: Desmop…
Excerpt only. Read the full label for complete information.
About NDC 59651-250
- What is NDC 59651-250?
- 59651-250 is the product NDC for Desmopressin Acetate, Desmopressin acetate .2 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. 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?
- Aurobindo Pharma Limited, NDC labeler code 59651. 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 213095
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 | Aurobindo Pharma Limited | 59651-249 |
| Desmopressin Acetate | Desmopressin acetate .1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4612 |