NDC codes

FDA NDC Directory
Product NDC (as listed)33342-536Labeler and product segments. Claims need a package NDC.
Product NDC at billing width33342-0536Add 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
33342-536-10333420536103334205361090 TABLET, FILM COATED in 1 BOTTLE (33342-536-10)Marketed from Jan 3, 2014
33342-536-66333420536663334205366610 TABLET, FILM COATED in 1 BLISTER PACK (33342-536-66)Marketed from Jan 3, 2014

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 — 20 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203814
Marketing start
Listing expires
Other FDA classes
Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers
Product ID 33342-536_d9ad8c65-3264-44dc-b6f9-bdef8467cdadSPL ID d9ad8c65-3264-44dc-b6f9-bdef8467cdadSPL set ID 61a0ebd9-8dc9-4bcc-b07b-f3d6398ea96eRxCUI 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

N433342053610 followed by a unit qualifier and the quantity

Package 33342-0536-10. 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 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 is 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 clinical worsening…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-536

What is NDC 33342-536?
33342-536 is the product NDC for Sildenafil, Sildenafil citrate 20 mg/1 tablet, film coated, listed with the FDA by Macleods Pharmaceuticals Limited. It has 2 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?
Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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 203814

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

FDA NDC Directory listings under ANDA 203814
ProductStrengthForm · routeLabelerProduct NDC
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-5115
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4517
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1005
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-597
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-2072
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralProficient Rx LP63187-813
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-061
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-121
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-788
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-363
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1638

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