What is NDC 43598-648?

43598-648 is the product NDC for Treprostinil, Treprostinil 200 mg/20mL injection, solution, listed with the FDA by Dr.Reddy's Laboratories Inc.,. It has 1 package NDC, shown above in 10- and 11-digit form.

Dr.Reddy's 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 Treprostinil?

15 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Treprostinil NDC 43598-648 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-648Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0648Add 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	Copy
43598-648-11	4359806481143598064811	1 VIAL in 1 CARTON (43598-648-11) / 20 mL in 1 VIALMarketed from Feb 13, 2023

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): Treprostinil
Generic name (nonproprietary): treprostinil
Active ingredients: Treprostinil — 200 mg/20mL
Dosage form: Injection, Solution
Route: Intravenous, Subcutaneous
Labeler: Dr.Reddy's Laboratories Inc.,NDC labeler code 43598
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210214
Marketing start: Feb 13, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Prostaglandins I (Chemical structure)Vasodilation (Physiologic effect)
Identifiers: Product ID 43598-648_61347918-bb33-236c-6a2e-280b59e7ab31SPL ID 61347918-bb33-236c-6a2e-280b59e7ab31SPL set ID 33050ee2-519b-1f0b-d4df-9e14dd329c57RxCUI 349407, 349408, 349409, 349410UNII 059QF0KO0R, RUM6K67ESGUPC 0343598126111
Pharmacologic class: Prostacycline Vasodilator

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

N443598064811 followed by a unit qualifier and the quantity

Package 43598-0648-11. 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 Dec 23, 2021.

Indications (excerpt from the label)

Treprostinil injection is a prostacyclin vasodilator indicated for: Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). ( 1.1 ) Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. ( 1.2 ) 1.1 Pulmonary Arterial Hypertension Treprostinil…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43598-648

What is NDC 43598-648?: 43598-648 is the product NDC for Treprostinil, Treprostinil 200 mg/20mL injection, solution, listed with the FDA by Dr.Reddy's Laboratories Inc.,. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Treprostinil.
What is the active ingredient?: Treprostinil.
Who is the labeler?: Dr.Reddy's 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 Treprostinil?: 15 other product NDCs are listed under this name. See all Treprostinil 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 Treprostinil NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Treprostinil	Treprostinil 50 mg/20mL	Injection, SolutionIntravenous, Subcutaneous	Dr.Reddy's Laboratories Inc.,	43598-646	43598-0646-11
Treprostinil	Treprostinil 100 mg/20mL	Injection, SolutionIntravenous, Subcutaneous	Dr.Reddy's Laboratories Inc.,	43598-647	43598-0647-11
Treprostinil	Treprostinil 20 mg/20mL	Injection, SolutionIntravenous, Subcutaneous	Dr.Reddy's Laboratories Inc.,	43598-649	43598-0649-11
Treprostinil	Treprostinil 20 mg/20mL	Injection, SolutionIntravenous, Subcutaneous	Alembic Pharmaceuticals Inc.	62332-514	62332-0514-20
Treprostinil	Treprostinil 50 mg/20mL	Injection, SolutionIntravenous, Subcutaneous	Alembic Pharmaceuticals Inc.	62332-515	62332-0515-20
Treprostinil	Treprostinil 100 mg/20mL	Injection, SolutionIntravenous, Subcutaneous	Alembic Pharmaceuticals Inc.	62332-516	62332-0516-20
Treprostinil	Treprostinil 200 mg/20mL	Injection, SolutionIntravenous, Subcutaneous	Alembic Pharmaceuticals Inc.	62332-517	62332-0517-20
Treprostinil	Treprostinil 20 mg/20mL	Injection, SolutionIntravenous, Subcutaneous	Teva Parenteral Medicines, Inc.	0703-0666	00703-0666-01
Treprostinil	Treprostinil 50 mg/20mL	Injection, SolutionIntravenous, Subcutaneous	Teva Parenteral Medicines, Inc.	0703-0676	00703-0676-01
Treprostinil	Treprostinil 100 mg/20mL	Injection, SolutionIntravenous, Subcutaneous	Teva Parenteral Medicines, Inc.	0703-0686	00703-0686-01

All 16 Treprostinil NDCs

Other NDCs under ANDA 210214

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

FDA NDC Directory listings under ANDA 210214
Product	Strength	Form · route	Labeler	Product NDC
Sterile Diluent for Treprostinilwater	Water 1 mL/mL	Injection, SolutionIntravenous	Dr.Reddy's Laboratories Inc.,	43598-126
Treprostinil	Treprostinil 50 mg/20mL	Injection, SolutionIntravenous, Subcutaneous	Dr.Reddy's Laboratories Inc.,	43598-646
Treprostinil	Treprostinil 100 mg/20mL	Injection, SolutionIntravenous, Subcutaneous	Dr.Reddy's Laboratories Inc.,	43598-647
Treprostinil	Treprostinil 20 mg/20mL	Injection, SolutionIntravenous, Subcutaneous	Dr.Reddy's Laboratories Inc.,	43598-649