NDC codes

FDA NDC Directory
Product NDC (as listed)65862-691Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65862-0691Add 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
65862-691-016586206910165862069101100 TABLET, FILM COATED in 1 BOTTLE (65862-691-01)Marketed from Jun 11, 2018
65862-691-056586206910565862069105500 TABLET, FILM COATED in 1 BOTTLE (65862-691-05)Marketed from Jun 11, 2018
65862-691-30658620691306586206913030 TABLET, FILM COATED in 1 BOTTLE (65862-691-30)Marketed from Jun 11, 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)
Sildenafil
Generic name (nonproprietary)
sildenafil
Active ingredients
Sildenafil citrate — 100 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Aurobindo Pharma LimitedNDC labeler code 65862
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203962
Marketing start
Listing expires
Other FDA classes
Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers
Product ID 65862-691_98bf3100-9a4e-45d5-9f6b-1fa1a06b26b8SPL ID 98bf3100-9a4e-45d5-9f6b-1fa1a06b26b8SPL set ID 363c1e77-e482-47b2-aa1e-851abd770aebRxCUI 312950, 314228, 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

N465862069101 followed by a unit qualifier and the quantity

Package 65862-0691-01. 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)

Sildenafil tablets are indicated for the treatment of erectile dysfunction. Sildenafil is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65862-691

What is NDC 65862-691?
65862-691 is the product NDC for Sildenafil, Sildenafil citrate 100 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. 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?
Aurobindo Pharma Limited, NDC labeler code 65862. 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 203962

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

FDA NDC Directory listings under ANDA 203962
ProductStrengthForm · routeLabelerProduct NDC
SildenafilSildenafil citrate 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7963
SildenafilSildenafil citrate 100 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7964
SildenafilSildenafil citrate 25 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-689
SildenafilSildenafil citrate 50 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-690
SildenafilSildenafil citrate 50 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3743
SildenafilSildenafil citrate 50 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3745
SildenafilSildenafil citrate 100 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3832
SildenafilSildenafil citrate 100 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-3908
SildenafilSildenafil citrate 100 mg/1Tablet, Film coatedOralProficient Rx LP71205-220

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