NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1649Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1649Add 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
71335-1649-0713351649007133516490050 TABLET, FILM COATED in 1 BOTTLE (71335-1649-0)Marketed from Mar 1, 2022
71335-1649-1713351649017133516490110 TABLET, FILM COATED in 1 BOTTLE (71335-1649-1)Marketed from Jul 9, 2020
71335-1649-2713351649027133516490230 TABLET, FILM COATED in 1 BOTTLE (71335-1649-2)Marketed from Jun 24, 2020
71335-1649-371335164903713351649037 TABLET, FILM COATED in 1 BOTTLE (71335-1649-3)Marketed from May 10, 2021
71335-1649-4713351649047133516490490 TABLET, FILM COATED in 1 BOTTLE (71335-1649-4)Marketed from Jun 23, 2020
71335-1649-5713351649057133516490560 TABLET, FILM COATED in 1 BOTTLE (71335-1649-5)Marketed from Mar 31, 2021
71335-1649-6713351649067133516490620 TABLET, FILM COATED in 1 BOTTLE (71335-1649-6)Marketed from Aug 13, 2020
71335-1649-77133516490771335164907270 TABLET, FILM COATED in 1 BOTTLE (71335-1649-7)Marketed from May 30, 2024
71335-1649-8713351649087133516490815 TABLET, FILM COATED in 1 BOTTLE (71335-1649-8)Marketed from Jul 12, 2021
71335-1649-9713351649097133516490912 TABLET, FILM COATED in 1 BOTTLE (71335-1649-9)Marketed from May 30, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Bryant Ranch PrepackNDC labeler code 71335
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 71335-1649_841b6c33-e16d-4bbb-80df-3c35c73287d3SPL ID 841b6c33-e16d-4bbb-80df-3c35c73287d3SPL set ID af5277be-124b-4541-b6b2-bb55246cb8edRxCUI 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

N471335164900 followed by a unit qualifier and the quantity

Package 71335-1649-00. 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 tablets are 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-1649

What is NDC 71335-1649?
71335-1649 is the product NDC for Sildenafil, Sildenafil citrate 20 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 10 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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 Prepack72162-2363
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals, Inc.72865-105

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