NDC codes

FDA NDC Directory
Product NDC (as listed)70771-1668Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70771-1668Add 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
70771-1668-4707711668041 BOTTLE, GLASS in 1 CARTON (70771-1668-4) / 112 mL in 1 BOTTLE, GLASSMarketed from Oct 27, 2022
70771-1668-5707711668051 BOTTLE, PLASTIC in 1 CARTON (70771-1668-5) / 112 mL in 1 BOTTLE, PLASTICMarketed from Oct 27, 2022

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 Citrate
Generic name (nonproprietary)
sildenafil citrate
Active ingredients
Sildenafil citrate — 10 mg/mL
Dosage form
Powder, For suspension
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215708
Marketing start
Listing expires
Other FDA classes
Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers
Product ID 70771-1668_37e37cf7-663e-45b8-8056-596b5fb6ac63SPL ID 37e37cf7-663e-45b8-8056-596b5fb6ac63SPL set ID 2ef4d02f-76ee-4f67-9f4f-1cd554decb31RxCUI 1307427UNII BW9B0ZE037UPC 0370771166848, 0370771166855
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

N470771166804 followed by a unit qualifier and the quantity

Package 70771-1668-04. 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 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 for oral suspension is a phosp…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 215708

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

FDA NDC Directory listings under ANDA 215708
ProductStrengthForm · routeLabelerProduct NDC
Sildenafil CitrateSildenafil citrate 10 mg/mLPowder, For suspensionOralZydus Pharmaceuticals (USA) Inc.70710-1716

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