Paroxetine NDC 68180-646

NDC codes

FDA NDC Directory

Product NDC (as listed)68180-646Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68180-0646Add 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
68180-646-06	68180064606	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-646-06)Marketed from Mar 6, 2017

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): Paroxetine
Generic name (nonproprietary): paroxetine
Active ingredients: Paroxetine hydrochloride hemihydrate — 25 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Lupin Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204134
Marketing start: Mar 6, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 68180-646_1a9bc25c-db83-42a0-851a-30212ee10cc6SPL ID 1a9bc25c-db83-42a0-851a-30212ee10cc6SPL set ID d315e0da-f829-408b-be5d-2bca2e06913cRxCUI 1738803, 1738805, 1738807UNII X2ELS050D8
Pharmacologic class: Serotonin Reuptake Inhibitor

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

N468180064606 followed by a unit qualifier and the quantity

Package 68180-0646-06. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 204134

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

FDA NDC Directory listings under ANDA 204134
Product	Strength	Form · route	Labeler	Product NDC
Paroxetine	Paroxetine hydrochloride hemihydrate 37.5 mg/1	Tablet, Film coated, Extended releaseOral	Lupin Pharmaceuticals, Inc.	68180-645
Paroxetine	Paroxetine hydrochloride hemihydrate 12.5 mg/1	Tablet, Film coated, Extended releaseOral	Lupin Pharmaceuticals, Inc.	68180-647