What is NDC 70069-821?

70069-821 is the product NDC for Prucalopride succinate, Prucalopride succinate 1 mg/1 tablet, listed with the FDA by Somerset Therapeutics, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Somerset Therapeutics, LLC, NDC labeler code 70069. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Prucalopride succinate?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Prucalopride succinate NDC 70069-821

NDC codes

FDA NDC Directory

Product NDC (as listed)70069-821Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70069-0821Add 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
70069-821-01	7006908210170069082101	1 BOTTLE in 1 BOTTLE (70069-821-01) / 30 TABLET in 1 BOTTLEMarketed from Jun 24, 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): Prucalopride succinate
Generic name (nonproprietary): prucalopride succinate
Active ingredients: Prucalopride succinate — 1 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Somerset Therapeutics, LLCNDC labeler code 70069
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219078
Marketing start: Jun 24, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin 4 Receptor Agonists (Mechanism)
Identifiers: Product ID 70069-821_7b3acc62-d656-47b8-91d2-5b30cd699fbdSPL ID 7b3acc62-d656-47b8-91d2-5b30cd699fbdSPL set ID 1750cd94-b443-49df-9c53-eb5b68f66092RxCUI 2107345, 2107353UNII 4V2G75E1CK
Pharmacologic class: Serotonin-4 Receptor Agonist

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

N470069082101 followed by a unit qualifier and the quantity

Package 70069-0821-01. 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 Jul 10, 2025.

Indications (excerpt from the label)

Prucalopride tablet is indicated for the treatment of chronic idiopathic constipation (CIC) in adults. Prucalopride tablet is a serotonin-4 (5-HT 4 ) receptor agonist indicated for the treatment of chronic idiopathic constipation (CIC) in adults. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70069-821

What is NDC 70069-821?: 70069-821 is the product NDC for Prucalopride succinate, Prucalopride succinate 1 mg/1 tablet, listed with the FDA by Somerset Therapeutics, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Prucalopride succinate.
What is the active ingredient?: Prucalopride succinate.
Who is the labeler?: Somerset Therapeutics, LLC, NDC labeler code 70069. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Prucalopride succinate?: 1 other product NDC are listed under this name. See all Prucalopride succinate 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 Prucalopride succinate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Prucalopride succinate	Prucalopride succinate 2 mg/1	TabletOral	Somerset Therapeutics, LLC	70069-822	70069-0822-01

Other NDCs under ANDA 219078

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

FDA NDC Directory listings under ANDA 219078
Product	Strength	Form · route	Labeler	Product NDC
Prucalopride succinate	Prucalopride succinate 2 mg/1	TabletOral	Somerset Therapeutics, LLC	70069-822