What is NDC 46708-078?

46708-078 is the product NDC for Prucalopride, Prucalopride succinate 2 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 46708-078 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-078Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0078Add 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
46708-078-30	4670800783046708007830	30 TABLET, FILM COATED in 1 BOTTLE (46708-078-30)Marketed from Jul 31, 2026

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: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219234
Marketing start: Jul 31, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin 4 Receptor Agonists (Mechanism)
Identifiers: Product ID 46708-078_89a7bdb1-e1cd-4986-bab9-a939dc764faaSPL ID 89a7bdb1-e1cd-4986-bab9-a939dc764faaSPL set ID 89a7bdb1-e1cd-4986-bab9-a939dc764faaRxCUI 2107345, 2107353UNII 4V2G75E1CKUPC 0346708077303, 0346708078300
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

N446708007830 followed by a unit qualifier and the quantity

Package 46708-0078-30. 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 31, 2026.

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 46708-078

What is NDC 46708-078?: 46708-078 is the product NDC for Prucalopride, Prucalopride succinate 2 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Limited. 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?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 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
Prucalopride	Prucalopride succinate 1 mg/1	Tablet, Film coatedOral	AvKARE	73190-038	73190-0038-30

All 34 Prucalopride NDCs

Other NDCs under ANDA 219234

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

FDA NDC Directory listings under ANDA 219234
Product	Strength	Form · route	Labeler	Product NDC
Prucalopride	Prucalopride succinate 1 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-077
Prucalopride	Prucalopride succinate 1 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-077
Prucalopride	Prucalopride succinate 2 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-078