NDC codes

FDA NDC Directory
Product NDC (as listed)0904-6671Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-6671Add 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
0904-6671-04009046671040090466710430 BLISTER PACK in 1 CARTON (0904-6671-04) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Nov 6, 2012
0904-6671-06009046671060090466710650 BLISTER PACK in 1 CARTON (0904-6671-06) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Nov 6, 2012

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Major PharmaceuticalsNDC labeler code 0904
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091479
Marketing start
Listing expires
Other FDA classes
Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers
Product ID 0904-6671_487513b4-e663-43d1-bd09-7eda0247460cSPL ID 487513b4-e663-43d1-bd09-7eda0247460cSPL set ID a65b5fb3-ca3c-4226-9caa-42fb9a2f7373RxCUI 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

N400904667104 followed by a unit qualifier and the quantity

Package 00904-6671-04. 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 citrate 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. ( 1 ) 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0904-6671

What is NDC 0904-6671?
0904-6671 is the product NDC for Sildenafil, Sildenafil citrate 20 mg/1 tablet, film coated, listed with the FDA by Major Pharmaceuticals. 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?
Major Pharmaceuticals, NDC labeler code 0904. 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 091479

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

FDA NDC Directory listings under ANDA 091479
ProductStrengthForm · routeLabelerProduct NDC
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralTorrent Pharmaceuticals Limited13668-185
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-4307
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3954
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2657
SildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralProficient Rx LP82804-243
Sildenafil CitrateSildenafil citrate 20 mg/1TabletOralA-S Medication Solutions50090-3905
Sildenafil CitrateSildenafil citrate 20 mg/1TabletOralAsclemed USA, Inc.76420-613
Sildenafil CitrateSildenafil citrate 20 mg/1TabletOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0304

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