Prescription drug · ANDA
Desmopressin Acetate NDC 23155-489
Desmopressin acetate .1 mg/1 · Tablet · Oral · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 23155-489-01 | 2315504890123155048901 | 100 TABLET in 1 BOTTLE (23155-489-01)Marketed from May 26, 2017 | |
| 23155-489-05 | 2315504890523155048905 | 500 TABLET in 1 BOTTLE (23155-489-05)Marketed from May 26, 2017 |
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 — .1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.NDC labeler code 23155
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207880
- 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 23155-489_3ed8c1cf-5b26-49fc-adb2-264572e68cbeSPL ID 3ed8c1cf-5b26-49fc-adb2-264572e68cbeSPL set ID e87b6cfd-5677-4398-883d-7ced5dd678efRxCUI 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
N423155048901followed by a unit qualifier and the quantityPackage 23155-0489-01. 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 Desmopre…
Excerpt only. Read the full label for complete information.
About NDC 23155-489
- What is NDC 23155-489?
- 23155-489 is the product NDC for Desmopressin Acetate, Desmopressin acetate .1 mg/1 tablet, listed with the FDA by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.. It has 2 package NDCs, 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?
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., NDC labeler code 23155. 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 207880
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 .2 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-490 |