Prescription drug · ANDA
Prucalopride NDC 0406-6302
Prucalopride 2 mg/1 · Tablet, Film coated · Oral · SpecGx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0406-6302-03 | 0040663020300406630203 | 30 TABLET, FILM COATED in 1 BOTTLE (0406-6302-03)Marketed from Jun 24, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 2 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- SpecGx LLCNDC labeler code 0406
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219193
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 4 Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0406-6302_ef151ce8-6bd9-4be8-9010-337ad85551b1SPL ID ef151ce8-6bd9-4be8-9010-337ad85551b1SPL set ID 70fced73-c25b-46cb-ad30-19328e6130c3RxCUI 2107345, 2107353UNII 0A09IUW5TPUPC 0304066302031, 0304066301034
- 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
N400406630203followed by a unit qualifier and the quantityPackage 00406-6302-03. 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 .
Indications (excerpt from the label)
Prucalopride tablet is indicated for the treatment of chronic idiopathic constipation (CIC) in adults. Prucalopride tablets are 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.
About NDC 0406-6302
- What is NDC 0406-6302?
- 0406-6302 is the product NDC for Prucalopride, Prucalopride 2 mg/1 tablet, film coated, listed with the FDA by SpecGx LLC. 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.
- Who is the labeler?
- SpecGx LLC, NDC labeler code 0406. 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.
Related NDCs: other Prucalopride products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |
Other NDCs under ANDA 219193
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Prucalopride | Prucalopride 1 mg/1 | Tablet, Film coatedOral | SpecGx LLC | 0406-6301 |