What is NDC 68083-642?

68083-642 is the product NDC for Epoprostenol, Epoprostenol 1.5 mg/10mL injection, powder, lyophilized, for solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Epoprostenol?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Epoprostenol NDC 68083-642 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-642Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0642Add 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
68083-642-01	68083064201	1 VIAL in 1 CARTON (68083-642-01) / 10 mL in 1 VIALMarketed from Dec 29, 2025

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): Epoprostenol
Generic name (nonproprietary): epoprostenol
Active ingredients: Epoprostenol — 1.5 mg/10mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Gland Pharma LimitedNDC labeler code 68083
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219237
Marketing start: Dec 29, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Prostaglandins I (Chemical structure)Vasodilation (Physiologic effect)
Identifiers: Product ID 68083-642_8b45ebae-92d6-4a3b-a559-115c66a8352aSPL ID 8b45ebae-92d6-4a3b-a559-115c66a8352aSPL set ID 47f64fcd-cbf7-457a-9548-661fb10ff7e0RxCUI 562501, 562502UNII DCR9Z582X0UPC 0368083707019, 0368083642013
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

N468083064201 followed by a unit qualifier and the quantity

Package 68083-0642-01. 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 Jan 6, 2026.

Indications (excerpt from the label)

Epoprostenol for Injection is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III–IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases. Epoprostenol for Injection is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III–IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with c…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68083-642

What is NDC 68083-642?: 68083-642 is the product NDC for Epoprostenol, Epoprostenol 1.5 mg/10mL injection, powder, lyophilized, for solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Epoprostenol.
What is the active ingredient?: Epoprostenol.
Who is the labeler?: Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Epoprostenol?: 5 other product NDCs are listed under this name. See all Epoprostenol 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 Epoprostenol NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Epoprostenol	Epoprostenol .5 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Gland Pharma Limited	68083-707	68083-0707-01
Epoprostenol	Epoprostenol .5 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Mylan Institutional LLC	67457-587	67457-0587-10
Epoprostenol	Epoprostenol 1.5 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Mylan Institutional LLC	67457-588	67457-0588-10
epoprostenol	Epoprostenol sodium .5 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Sun Pharmaceutical Industries, Inc.	62756-059	62756-0059-40
epoprostenol	Epoprostenol sodium 1.5 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Sun Pharmaceutical Industries, Inc.	62756-060	62756-0060-40

Other NDCs under ANDA 219237

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

FDA NDC Directory listings under ANDA 219237
Product	Strength	Form · route	Labeler	Product NDC
Epoprostenol	Epoprostenol .5 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Gland Pharma Limited	68083-707