What is NDC 71610-056?

71610-056 is the product NDC for Paroxetine, Paroxetine hydrochloride hemihydrate 40 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Paroxetine hydrochloride hemihydrate.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Paroxetine?

145 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Paroxetine NDC 71610-056 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-056Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0056Add 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
71610-056-15	7161000561571610005615	15 TABLET, FILM COATED in 1 BOTTLE (71610-056-15)Marketed from May 2, 2018
71610-056-45	7161000564571610005645	45 TABLET, FILM COATED in 1 BOTTLE (71610-056-45)Marketed from May 2, 2018

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 — 40 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078406
Marketing start: Dec 3, 2009
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 71610-056_dc77c275-c420-46bc-863a-cfe7ef2881beSPL ID dc77c275-c420-46bc-863a-cfe7ef2881beSPL set ID 30fd2fc4-f661-44c9-a9a9-9d0de0892e3cRxCUI 1738511UNII 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

N471610005615 followed by a unit qualifier and the quantity

Package 71610-0056-15. 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 May 8, 2018. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Major Depressive Disorder Paroxetine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of paroxetine in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see CLINICAL PHARMACOLOGY: Clinical Trials ). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: Change in appetite, change in sleep, psychom…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-056

What is NDC 71610-056?: 71610-056 is the product NDC for Paroxetine, Paroxetine hydrochloride hemihydrate 40 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Paroxetine.
What is the active ingredient?: Paroxetine hydrochloride hemihydrate.
Who is the labeler?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Paroxetine?: 145 other product NDCs are listed under this name. See all Paroxetine 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 Paroxetine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Paroxetineparoxetine hydrochloride hemihydrate	Paroxetine hydrochloride 20 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4130	68788-4130-0168788-4130-0368788-4130-06+2 more
Paroxetine	Paroxetine hydrochloride hemihydrate 40 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0446	67046-0446-03
Paroxetine	Paroxetine hydrochloride hemihydrate 30 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0846	67046-0846-03
Paroxetine	Paroxetine hydrochloride hemihydrate 12.5 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-766	46708-0766-3046708-0766-91
Paroxetine	Paroxetine hydrochloride hemihydrate 12.5 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-766	62332-0766-3062332-0766-91
Paroxetine	Paroxetine hydrochloride hemihydrate 25 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-767	46708-0767-3046708-0767-91
Paroxetine	Paroxetine hydrochloride hemihydrate 37.5 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-768	46708-0768-3046708-0768-91
Paroxetine	Paroxetine hydrochloride hemihydrate 25 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-767	62332-0767-3062332-0767-91
Paroxetine	Paroxetine hydrochloride hemihydrate 37.5 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-768	62332-0768-3062332-0768-91
Paroxetineparoxetine hydrochloride hemihydrate	Paroxetine hydrochloride 10 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8829	68788-8829-0168788-8829-0368788-8829-06+2 more

All 146 Paroxetine NDCs

Other NDCs under ANDA 078406

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

FDA NDC Directory listings under ANDA 078406
Product	Strength	Form · route	Labeler	Product NDC
Paroxetine	Paroxetine hydrochloride hemihydrate 20 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	43353-713
Paroxetine	Paroxetine hydrochloride hemihydrate 30 mg/1	Tablet, Film coatedOral	Aurolife Pharma LLC	13107-156
Paroxetine	Paroxetine hydrochloride hemihydrate 10 mg/1	Tablet, Film coatedOral	Aurolife Pharma LLC	13107-154
Paroxetine	Paroxetine hydrochloride hemihydrate 20 mg/1	Tablet, Film coatedOral	Aurolife Pharma LLC	13107-155
Paroxetine	Paroxetine hydrochloride hemihydrate 40 mg/1	Tablet, Film coatedOral	Aurolife Pharma LLC	13107-157
Paroxetine	Paroxetine hydrochloride hemihydrate 40 mg/1	Tablet, Film coatedOral	AvPAK	50268-643
Paroxetine	Paroxetine hydrochloride hemihydrate 10 mg/1	Tablet, Film coatedOral	AvPAK	50268-640
Paroxetine	Paroxetine hydrochloride hemihydrate 30 mg/1	Tablet, Film coatedOral	AvPAK	50268-642
Paroxetine	Paroxetine hydrochloride 10 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8359
Paroxetine	Paroxetine hydrochloride hemihydrate 10 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-2574
Paroxetine	Paroxetine hydrochloride hemihydrate 20 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-564
Paroxetineparoxetine hydrochloride	Paroxetine hydrochloride hemihydrate 20 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	16714-182
Paroxetineparoxetine hydrochloride	Paroxetine hydrochloride hemihydrate 10 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	16714-181
Paroxetineparoxetine hydrochloride	Paroxetine hydrochloride hemihydrate 30 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	16714-183
Paroxetineparoxetine hydrochloride	Paroxetine hydrochloride hemihydrate 40 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	16714-184
Paroxetineparoxetine hydrochloride	Paroxetine hydrochloride hemihydrate 40 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-157
Paroxetineparoxetine hydrochloride	Paroxetine hydrochloride hemihydrate 10 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-154
Paroxetineparoxetine hydrochloride	Paroxetine hydrochloride hemihydrate 20 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-155
Paroxetineparoxetine hydrochloride	Paroxetine hydrochloride hemihydrate 30 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-156