What is NDC 69097-219?

69097-219 is the product NDC for Prucalopride, Prucalopride succinate 2 mg/1 tablet, film coated, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Cipla USA Inc., NDC labeler code 69097. 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?

33 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Prucalopride NDC 69097-219 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-219Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0219Add 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
69097-219-02	6909702190269097021902	30 TABLET, FILM COATED in 1 BOTTLE (69097-219-02)Marketed from Jun 25, 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
Generic name (nonproprietary): prucalopride
Active ingredients: Prucalopride succinate — 2 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Cipla USA Inc.NDC labeler code 69097
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218795
Marketing start: Jun 25, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin 4 Receptor Agonists (Mechanism)
Identifiers: Product ID 69097-219_8dae2208-69a9-4580-9244-bc835f6cb29dSPL ID 8dae2208-69a9-4580-9244-bc835f6cb29dSPL set ID e1306d74-8b35-4387-a89d-7c50be4bfc4fRxCUI 2107345, 2107353UNII 4V2G75E1CKUPC 0369097219024, 0369097218027
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

N469097021902 followed by a unit qualifier and the quantity

Package 69097-0219-02. 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 Nov 1, 2024.

Indications (excerpt from the label)

Prucalopride tablets are 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 69097-219

What is NDC 69097-219?: 69097-219 is the product NDC for Prucalopride, Prucalopride succinate 2 mg/1 tablet, film coated, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Prucalopride.
What is the active ingredient?: Prucalopride succinate.
Who is the labeler?: Cipla USA Inc., NDC labeler code 69097. 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?: 33 other product NDCs are listed under this name. See all Prucalopride 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 NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Prucalopride	Prucalopride succinate 1 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-077	46708-0077-30
Prucalopride	Prucalopride succinate 2 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-078	46708-0078-30
Prucalopride	Prucalopride succinate 1 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-077	62332-0077-30
Prucalopride	Prucalopride succinate 2 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-078	62332-0078-30
prucalopride	Prucalopride succinate 1 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1899	70771-1899-03
prucalopride	Prucalopride succinate 2 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1900	70771-1900-03
prucalopride	Prucalopride succinate 1 mg/1	Tablet, Film coatedOral	Viona Pharmaceuticals Inc	72578-221	72578-0221-06
prucalopride	Prucalopride succinate 2 mg/1	Tablet, Film coatedOral	Viona Pharmaceuticals Inc	72578-222	72578-0222-06
Prucalopride	Prucalopride 1 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-294	27241-0294-30
Prucalopride	Prucalopride 2 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-295	27241-0295-30

All 34 Prucalopride NDCs

Other NDCs under ANDA 218795

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

FDA NDC Directory listings under ANDA 218795
Product	Strength	Form · route	Labeler	Product NDC
Prucalopride	Prucalopride succinate 1 mg/1	Tablet, Film coatedOral	Cipla USA Inc.	69097-218