Sildenafil NDC 71335-1638

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-1638Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-1638Add 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 NDC	11-digit (billing)	Package
71335-1638-1	71335163801	10 TABLET, FILM COATED in 1 BOTTLE (71335-1638-1)Marketed from Jan 3, 2014
71335-1638-2	71335163802	30 TABLET, FILM COATED in 1 BOTTLE (71335-1638-2)Marketed from Jan 3, 2014
71335-1638-3	71335163803	7 TABLET, FILM COATED in 1 BOTTLE (71335-1638-3)Marketed from Jan 3, 2014
71335-1638-4	71335163804	90 TABLET, FILM COATED in 1 BOTTLE (71335-1638-4)Marketed from Jan 3, 2014
71335-1638-5	71335163805	60 TABLET, FILM COATED in 1 BOTTLE (71335-1638-5)Marketed from Jan 3, 2014
71335-1638-6	71335163806	20 TABLET, FILM COATED in 1 BOTTLE (71335-1638-6)Marketed from Jan 3, 2014
71335-1638-7	71335163807	270 TABLET, FILM COATED in 1 BOTTLE (71335-1638-7)Marketed from Jan 3, 2014
71335-1638-8	71335163808	15 TABLET, FILM COATED in 1 BOTTLE (71335-1638-8)Marketed from Jan 3, 2014
71335-1638-9	71335163809	12 TABLET, FILM COATED in 1 BOTTLE (71335-1638-9)Marketed from Jan 3, 2014

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 Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203814
Marketing start: Jan 3, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers: Product ID 71335-1638_68ec1574-866c-495a-a4e9-5631d24b2b04SPL ID 68ec1574-866c-495a-a4e9-5631d24b2b04SPL set ID 85767ed7-932b-4e2b-8bba-b59bb45ce116RxCUI 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

N471335163801 followed by a unit qualifier and the quantity

Package 71335-1638-01. 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 Sep 18, 2020.

Indications (excerpt from the label)

Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy [ see Clinical Studies (14) ]. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%). Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacit…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203814

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

FDA NDC Directory listings under ANDA 203814
Product	Strength	Form · route	Labeler	Product NDC
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-788
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-5115
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-2072
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4517
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-121
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1005
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-536
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	BluePoint Laboratories	68001-597
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-061
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-813
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	BluePoint Laboratories	68001-363