NDC codes

FDA NDC Directory
Product NDC (as listed)43063-982Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43063-0982Add 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
43063-982-104306309821010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-982-10)Marketed from Aug 8, 2019
43063-982-304306309823030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-982-30)Marketed from May 1, 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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203963
Marketing start
Listing expires
Other FDA classes
Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers
Product ID 43063-982_5374d5cb-33b1-c2bd-e063-6294a90ab24eSPL ID 5374d5cb-33b1-c2bd-e063-6294a90ab24eSPL set ID 4ca5555d-fd45-467b-8b1d-4fbe1404f1f3RxCUI 577033UNII BW9B0ZE037UPC 0343063982303
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

N443063098210 followed by a unit qualifier and the quantity

Package 43063-0982-10. 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 worsenin…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203963

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

FDA NDC Directory listings under ANDA 203963
ProductStrengthForm · routeLabelerProduct NDC
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-688

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