NDC codes

FDA NDC Directory
Product NDC (as listed)72865-105Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72865-0105Add 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
72865-105-90728650105907286501059090 TABLET, FILM COATED in 1 BOTTLE (72865-105-90)Marketed from Jul 10, 2019

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
XLCare Pharmaceuticals, Inc.NDC labeler code 72865
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203623
Marketing start
Listing expires
Other FDA classes
Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers
Product ID 72865-105_f26fd814-a6cb-4749-e053-2a95a90a26fbSPL ID f26fd814-a6cb-4749-e053-2a95a90a26fbSPL set ID 22d70b8d-41bc-416d-89e9-e4c39db0af83RxCUI 577033UNII BW9B0ZE037UPC 0372865131305
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

N472865010590 followed by a unit qualifier and the quantity

Package 72865-0105-90. 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 pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy [see Clinical Studies (14)] . Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II to III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%). Limitation of Use : Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capa…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72865-105

What is NDC 72865-105?
72865-105 is the product NDC for Sildenafil, Sildenafil citrate 20 mg/1 tablet, film coated, listed with the FDA by XLCare Pharmaceuticals, Inc.. It has 1 package NDC, 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?
XLCare Pharmaceuticals, Inc., NDC labeler code 72865. 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 203623

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

FDA NDC Directory listings under ANDA 203623
ProductStrengthForm · routeLabelerProduct NDC
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-776
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5236
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralProficient Rx LP63187-619
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-2213
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1649
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2363

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