What is NDC 71610-679?

71610-679 is the product NDC for Sildenafil, Sildenafil citrate 50 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

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 Sildenafil?

150 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sildenafil NDC 71610-679 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-679Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0679Add 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
71610-679-02	7161006790271610067902	2 TABLET in 1 BOTTLE (71610-679-02)Marketed from Dec 2, 2022
71610-679-04	7161006790471610067904	4 TABLET in 1 BOTTLE (71610-679-04)Marketed from Dec 13, 2022
71610-679-06	7161006790671610067906	6 TABLET in 1 BOTTLE (71610-679-06)Marketed from Dec 13, 2022

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): Sildenafil
Generic name (nonproprietary): sildenafil
Active ingredients: Sildenafil citrate — 50 mg/1
Dosage form: Tablet
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 207178
Marketing start: Jul 1, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers: Product ID 71610-679_f4dbdb1b-c31d-4418-abd9-883eef04d5bdSPL ID f4dbdb1b-c31d-4418-abd9-883eef04d5bdSPL set ID cdab7ef5-39cb-45cc-b2bf-5f634f2f5499RxCUI 312950, 314229UNII BW9B0ZE037
Pharmacologic class: Phosphodiesterase 5 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

N471610067902 followed by a unit qualifier and the quantity

Package 71610-0679-02. 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 9, 2023.

Indications (excerpt from the label)

Sildenafil tablets are indicated for the treatment of erectile dysfunction. Sildenafil tablets is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-679

What is NDC 71610-679?: 71610-679 is the product NDC for Sildenafil, Sildenafil citrate 50 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sildenafil.
What is the active ingredient?: Sildenafil citrate.
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 Sildenafil?: 150 other product NDCs are listed under this name. See all Sildenafil 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 Sildenafil NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Sildenafil	Sildenafil citrate 25 mg/1	Tablet, Film coatedOral	Jubilant Cadista Pharmaceuticals Inc.	59746-434	59746-0434-0359746-0434-0459746-0434-05+2 more
Sildenafil	Sildenafil citrate 50 mg/1	Tablet, Film coatedOral	Jubilant Cadista Pharmaceuticals Inc.	59746-435	59746-0435-0159746-0435-0359746-0435-04+3 more
Sildenafil	Sildenafil citrate 100 mg/1	Tablet, Film coatedOral	Jubilant Cadista Pharmaceuticals Inc.	59746-436	59746-0436-0159746-0436-0359746-0436-04+3 more
Sildenafil	Sildenafil citrate 20 mg/1	TabletOral	REMEDYREPACK INC.	70518-4596	70518-4596-00
Sildenafilsildenafil citrate	Sildenafil citrate 25 mg/1	FilmOral	Yaral Pharma Inc.	82347-0205	82347-0205-0482347-0205-0582347-0205-06
Sildenafilsildenafil citrate	Sildenafil citrate 50 mg/1	FilmOral	Yaral Pharma Inc.	82347-0210	82347-0210-0482347-0210-0582347-0210-06
Sildenafilsildenafil citrate	Sildenafil citrate 75 mg/1	FilmOral	Yaral Pharma Inc.	82347-0215	82347-0215-0482347-0215-0582347-0215-06
Sildenafilsildenafil citrate	Sildenafil citrate 100 mg/1	FilmOral	Yaral Pharma Inc.	82347-0220	82347-0220-0482347-0220-0582347-0220-06
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-987	51407-0987-90
Sildenafil	Sildenafil citrate 20 mg/1	TabletOral	AvKARE	42291-937	42291-0937-90

All 151 Sildenafil NDCs

Other NDCs under ANDA 207178

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

FDA NDC Directory listings under ANDA 207178
Product	Strength	Form · route	Labeler	Product NDC
Sildenafil	Sildenafil citrate 25 mg/1	TabletOral	Appco Pharma LLC	55801-338
Sildenafil	Sildenafil citrate 50 mg/1	TabletOral	Appco Pharma LLC	55801-339
Sildenafil	Sildenafil citrate 100 mg/1	TabletOral	Appco Pharma LLC	55801-340
Sildenafil	Sildenafil citrate 25 mg/1	TabletOral	CIPLA USA INC.,	69097-951
Sildenafil	Sildenafil citrate 50 mg/1	TabletOral	CIPLA USA INC.,	69097-952
Sildenafil	Sildenafil citrate 100 mg/1	TabletOral	CIPLA USA INC.,	69097-953
Sildenafil	Sildenafil citrate 100 mg/1	TabletOral	Proficient Rx LP	71205-473
Sildenafil	Sildenafil citrate 100 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-675
Sildenafil	Sildenafil citrate 25 mg/1	TabletOral	Exelan Pharmaceuticals, Inc.	76282-643
Sildenafil	Sildenafil citrate 50 mg/1	TabletOral	Exelan Pharmaceuticals, Inc.	76282-644
Sildenafil	Sildenafil citrate 100 mg/1	TabletOral	Exelan Pharmaceuticals, Inc.	76282-645