NDC codes

FDA NDC Directory
Product NDC (as listed)59651-420Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59651-0420Add 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
59651-420-1159651042011596510420111 BOTTLE in 1 CARTON (59651-420-11) / 112 mL in 1 BOTTLEMarketed from Dec 23, 2022

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 CITRATE
Generic name (nonproprietary)
sildenafil citrate
Active ingredients
Sildenafil citrate — 10 mg/mL
Dosage form
Powder, For suspension
Route
Oral
Labeler
Aurobindo Pharma LimitedNDC labeler code 59651
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214773
Marketing start
Listing expires
Other FDA classes
Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers
Product ID 59651-420_39509319-16be-4fc4-a60a-48ea8e9333c6SPL ID 39509319-16be-4fc4-a60a-48ea8e9333c6SPL set ID b60b4fdc-9b78-45e6-8438-8a30f83ed976RxCUI 1307427UNII 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

N459651042011 followed by a unit qualifier and the quantity

Package 59651-0420-11. 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 for oral suspension is 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 Patients (1 to 17 Years Old) Sildenafil for oral suspension is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underlie improvements in exercise [see Clinical Studies (14) ]. Adults Sildenafil is a phosphodiesterase-5 (PDE-5…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59651-420

What is NDC 59651-420?
59651-420 is the product NDC for sildenafil CITRATE, Sildenafil citrate 10 mg/mL powder, for suspension, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
sildenafil CITRATE.
What is the active ingredient?
Sildenafil citrate.
Who is the labeler?
Aurobindo Pharma Limited, NDC labeler code 59651. 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 CITRATE?
69 other product NDCs are listed under this name. See all sildenafil CITRATE 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 CITRATE NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Sildenafil CitratesildenafilSildenafil citrate 100 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-411168788-4111-0168788-4111-0368788-4111-07
Sildenafil CitrateSildenafil citrate 25 mg/1TabletOralNorthstar Rx LLC72603-88372603-0883-01
Sildenafil CitrateSildenafil citrate 50 mg/1TabletOralNorthstar Rx LLC72603-88472603-0884-01
Sildenafil CitrateSildenafil citrate 100 mg/1TabletOralNorthstar Rx LLC72603-88572603-0885-0172603-0885-02
Sildenafil CitrateSildenafil citrate 50 mg/1Tablet, Film coatedOralUmedica Laboratories USA Inc.60290-00260290-0002-0160290-0002-0260290-0002-03+1 more
Sildenafil CitrateSildenafil citrate 100 mg/1Tablet, Film coatedOralUmedica Laboratories USA Inc.60290-00360290-0003-0160290-0003-0260290-0003-03+2 more
Sildenafil CitrateSildenafil citrate 25 mg/1Tablet, Film coatedOralUmedica Laboratories USA Inc.60290-07960290-0079-0160290-0079-0260290-0079-03+1 more
Sildenafil CitratesildenafilSildenafil citrate 20 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC82868-09482868-0094-30
Sildenafil CitrateSildenafil citrate 100 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-050380425-0503-0180425-0503-0280425-0503-03
Sildenafil CitrateSildenafil citrate 100 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-880468788-8804-0168788-8804-0368788-8804-07

All 70 sildenafil CITRATE NDCs

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