NDC codes

FDA NDC Directory
Product NDC (as listed)63187-813Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0813Add 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
63187-813-106318708131010 TABLET, FILM COATED in 1 BOTTLE (63187-813-10)Marketed from Feb 1, 2017
63187-813-306318708133030 TABLET, FILM COATED in 1 BOTTLE (63187-813-30)Marketed from Feb 1, 2017
63187-813-506318708135050 TABLET, FILM COATED in 1 BOTTLE (63187-813-50)Marketed from Feb 1, 2017
63187-813-606318708136060 TABLET, FILM COATED in 1 BOTTLE (63187-813-60)Marketed from Feb 1, 2017
63187-813-906318708139090 TABLET, FILM COATED in 1 BOTTLE (63187-813-90)Marketed from Feb 1, 2017

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
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 63187-813_46ab16a5-1f10-4772-97c6-272c4d28164eSPL ID 46ab16a5-1f10-4772-97c6-272c4d28164eSPL set ID 2538995d-2df6-4c87-978a-5513c670b60fRxCUI 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

N463187081310 followed by a unit qualifier and the quantity

Package 63187-0813-10. 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)

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-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%). Sildenafil is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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 coatedOralAmerican Health Packaging60687-788
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-5115
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-2072
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4517
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-121
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1005
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-536
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-597
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-061
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1638
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-363

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