NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1963Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1963Add 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 NDC11-digit (billing)PackageCopy
71335-1963-0713351963007133519630050 TABLET in 1 BOTTLE (71335-1963-0)Marketed from Feb 14, 2022
71335-1963-1713351963017133519630110 TABLET in 1 BOTTLE (71335-1963-1)Marketed from Feb 14, 2022
71335-1963-2713351963027133519630230 TABLET in 1 BOTTLE (71335-1963-2)Marketed from Oct 6, 2021
71335-1963-371335196303713351963037 TABLET in 1 BOTTLE (71335-1963-3)Marketed from Feb 14, 2022
71335-1963-4713351963047133519630490 TABLET in 1 BOTTLE (71335-1963-4)Marketed from Nov 22, 2021
71335-1963-5713351963057133519630560 TABLET in 1 BOTTLE (71335-1963-5)Marketed from Feb 14, 2022
71335-1963-6713351963067133519630620 TABLET in 1 BOTTLE (71335-1963-6)Marketed from Nov 29, 2021
71335-1963-77133519630771335196307270 TABLET in 1 BOTTLE (71335-1963-7)Marketed from Feb 14, 2022
71335-1963-8713351963087133519630815 TABLET in 1 BOTTLE (71335-1963-8)Marketed from Feb 14, 2022
71335-1963-9713351963097133519630912 TABLET in 1 BOTTLE (71335-1963-9)Marketed from Feb 14, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 20 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210394
Marketing start
Listing expires
Other FDA classes
Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers
Product ID 71335-1963_8cf40711-534a-4663-9a3b-d92dcc1fe0e9SPL ID 8cf40711-534a-4663-9a3b-d92dcc1fe0e9SPL set ID fe848310-57d8-4492-829c-3e2535754a55RxCUI 577033UNII 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

N471335196300 followed by a unit qualifier and the quantity

Package 71335-1963-00. 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)

Adults Sildenafil tablets, USP are indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies ( 14 )]. Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information. Adults Sildenafil tablets are a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clin…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-1963

What is NDC 71335-1963?
71335-1963 is the product NDC for Sildenafil, Sildenafil citrate 20 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
SildenafilSildenafil citrate 25 mg/1Tablet, Film coatedOralJubilant Cadista Pharmaceuticals Inc.59746-43459746-0434-0359746-0434-0459746-0434-05+2 more
SildenafilSildenafil citrate 50 mg/1Tablet, Film coatedOralJubilant Cadista Pharmaceuticals Inc.59746-43559746-0435-0159746-0435-0359746-0435-04+3 more
SildenafilSildenafil citrate 100 mg/1Tablet, Film coatedOralJubilant Cadista Pharmaceuticals Inc.59746-43659746-0436-0159746-0436-0359746-0436-04+3 more
SildenafilSildenafil citrate 20 mg/1TabletOralREMEDYREPACK INC.70518-459670518-4596-00
Sildenafilsildenafil citrateSildenafil citrate 25 mg/1FilmOralYaral Pharma Inc.82347-020582347-0205-0482347-0205-0582347-0205-06
Sildenafilsildenafil citrateSildenafil citrate 50 mg/1FilmOralYaral Pharma Inc.82347-021082347-0210-0482347-0210-0582347-0210-06
Sildenafilsildenafil citrateSildenafil citrate 75 mg/1FilmOralYaral Pharma Inc.82347-021582347-0215-0482347-0215-0582347-0215-06
Sildenafilsildenafil citrateSildenafil citrate 100 mg/1FilmOralYaral Pharma Inc.82347-022082347-0220-0482347-0220-0582347-0220-06
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-98751407-0987-90
SildenafilSildenafil citrate 20 mg/1TabletOralAvKARE42291-93742291-0937-90

All 151 Sildenafil NDCs

Other NDCs under ANDA 210394

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

FDA NDC Directory listings under ANDA 210394
ProductStrengthForm · routeLabelerProduct NDC
SildenafilSildenafil citrate 20 mg/1TabletOralAjanta Pharma USA Inc.27241-124
SildenafilSildenafil citrate 20 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-2537
SildenafilSildenafil citrate 20 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-2602
SildenafilSildenafil citrate 20 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-7974
SildenafilSildenafil citrate 20 mg/1TabletOralREMEDYREPACK INC.70518-3433
SildenafilSildenafil citrate 20 mg/1TabletOralDirectRx72189-298
SildenafilSildenafil citrate 20 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-094
SildenafilSildenafil citrate 20 mg/1TabletOralProficient Rx LP82804-185

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