What is NDC 59385-041?

59385-041 is the product NDC for Symproic (naldemedine), Naldemedine tosylate .2 mg/1 tablet, listed with the FDA by BioDelivery Sciences International Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

BioDelivery Sciences International Inc, NDC labeler code 59385. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Symproic?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Symproic NDC 59385-041 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)59385-041Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59385-0041Add 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
59385-041-30	59385004130	30 TABLET in 1 BOTTLE, PLASTIC (59385-041-30)Marketed from Jun 14, 2019

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): Symproic
Generic name (nonproprietary): naldemedine
Active ingredients: Naldemedine tosylate — .2 mg/1
Dosage form: Tablet
Route: Oral
Labeler: BioDelivery Sciences International IncNDC labeler code 59385
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 208854
Marketing start: Jun 14, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Opioid Antagonists (Mechanism)
Identifiers: Product ID 59385-041_7ce44be3-47a7-411e-ad1f-a2efc4916425SPL ID 7ce44be3-47a7-411e-ad1f-a2efc4916425SPL set ID b1a1256c-a1eb-4abe-ab1e-30e4711afd16RxCUI 1876603, 1876609UNII V1N8F1RVVOUPC 0359385041307
Pharmacologic class: Opioid Antagonist

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

N459385004130 followed by a unit qualifier and the quantity

Package 59385-0041-30. 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 Jul 25, 2025.

Indications (excerpt from the label)

SYMPROIC is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. SYMPROIC is an opioid antagonist indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59385-041

What is NDC 59385-041?: 59385-041 is the product NDC for Symproic (naldemedine), Naldemedine tosylate .2 mg/1 tablet, listed with the FDA by BioDelivery Sciences International Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Symproic (Naldemedine).
What is the active ingredient?: Naldemedine tosylate.
Who is the labeler?: BioDelivery Sciences International Inc, NDC labeler code 59385. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Symproic?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Symproic (Naldemedine) NDC 59385-041