NDC codes

FDA NDC Directory
Product NDC (as listed)43598-931Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43598-0931Add 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 NDC11-digit (billing)PackageCopy
43598-931-09435980931094359809310910 AMPULE in 1 BOX (43598-931-09) / 1 mL in 1 AMPULEMarketed from Apr 3, 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 — 4 ug/mL
Dosage form
Injection
Route
Intravenous, Subcutaneous
Labeler
Dr.Reddys' Laboratories IncNDC labeler code 43598
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210218
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 43598-931_bf0a845a-fd5e-48e2-f068-1d080d97ff40SPL ID bf0a845a-fd5e-48e2-f068-1d080d97ff40SPL set ID 15179e0c-f677-307f-d1e1-5910de4c212fRxCUI 1723232UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N443598093109 followed by a unit qualifier and the quantity

Package 43598-0931-09. 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 Hemophilia A: Desmopressin Acetate Injection 4 mcg/mL is indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5%. Desmopressin Acetate Injection will often maintain hemostasis in patients with hemophilia A during surgical procedures and postoperatively when administered 30 minutes prior to scheduled procedure. Desmopressin Acetate Injection will also stop bleeding in hemophilia A patients with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding. Desmopressin Acetate Injection is not indicated for the treatment of hemophilia A with factor VIII coagulant activity l…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43598-931

What is NDC 43598-931?
43598-931 is the product NDC for Desmopressin Acetate, Desmopressin acetate 4 ug/mL injection, listed with the FDA by Dr.Reddys' Laboratories Inc. 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?
Dr.Reddys' Laboratories Inc, NDC labeler code 43598. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Desmopressin Acetate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Desmopressin AcetateDesmopressin acetate 4 ug/mLInjection, SolutionIntravenous, SubcutaneousThe J. Molner Company LLC83148-12683148-0126-01
Desmopressin AcetateDesmopressin acetate 4 ug/mLInjection, SolutionIntravenous, SubcutaneousArmas Pharmaceuticals Inc.72485-52372485-0523-10
Desmopressin AcetateDesmopressin acetate 40 ug/10mLInjection, SolutionIntravenous, SubcutaneousArmas Pharmaceuticals Inc.72485-52472485-0524-01
Desmopressin AcetateDesmopressin acetate .1 mg/1TabletOralREMEDYREPACK INC.70518-461270518-4612-00
Desmopressin AcetateDesmopressin acetate 4 ug/mLInjection, SolutionIntravenousCaplin Steriles Limited65145-18365145-0183-10
Desmopressin AcetateDesmopressin acetate 4 ug/mLInjection, SolutionIntravenousCaplin Steriles Limited65145-18465145-0184-01
Desmopressin acetateDesmopressin acetate 4 ug/mLInjectionIntravenous, SubcutaneousMeitheal Pharmaceuticals Inc.71288-44071288-0440-02
Desmopressin acetateDesmopressin acetate 4 ug/mLInjectionIntravenous, SubcutaneousMeitheal Pharmaceuticals Inc.71288-44171288-0441-10
Desmopressin AcetateDesmopressin acetate .1 mg/mLSolutionNasalOceanside Pharmaceuticals68682-34268682-0342-05
Desmopressin AcetateDesmopressin acetate 4 ug/mLInjection, SolutionIntravenous, SubcutaneousXGen Pharmaceuticals DJB, Inc.39822-620039822-6200-02

All 49 Desmopressin Acetate NDCs

Other NDCs under ANDA 210218

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

FDA NDC Directory listings under ANDA 210218
ProductStrengthForm · routeLabelerProduct NDC
Desmopressin AcetateDesmopressin acetate 4 ug/mLInjectionIntravenous, SubcutaneousUBI Pharma Inc.72843-459

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