What is NDC 71335-1638?

71335-1638 is the product NDC for Sildenafil, Sildenafil citrate 20 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 9 package NDCs, shown above in 10- and 11-digit form.

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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sildenafil NDC 71335-1638 | National Drug Code

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	7133516380171335163801	10 TABLET, FILM COATED in 1 BOTTLE (71335-1638-1)Marketed from Jan 3, 2014
71335-1638-2	7133516380271335163802	30 TABLET, FILM COATED in 1 BOTTLE (71335-1638-2)Marketed from Jan 3, 2014
71335-1638-3	7133516380371335163803	7 TABLET, FILM COATED in 1 BOTTLE (71335-1638-3)Marketed from Jan 3, 2014
71335-1638-4	7133516380471335163804	90 TABLET, FILM COATED in 1 BOTTLE (71335-1638-4)Marketed from Jan 3, 2014
71335-1638-5	7133516380571335163805	60 TABLET, FILM COATED in 1 BOTTLE (71335-1638-5)Marketed from Jan 3, 2014
71335-1638-6	7133516380671335163806	20 TABLET, FILM COATED in 1 BOTTLE (71335-1638-6)Marketed from Jan 3, 2014
71335-1638-7	7133516380771335163807	270 TABLET, FILM COATED in 1 BOTTLE (71335-1638-7)Marketed from Jan 3, 2014
71335-1638-8	7133516380871335163808	15 TABLET, FILM COATED in 1 BOTTLE (71335-1638-8)Marketed from Jan 3, 2014
71335-1638-9	7133516380971335163809	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 PrepackNDC labeler code 71335
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)

About NDC 71335-1638

What is NDC 71335-1638?: 71335-1638 is the product NDC for Sildenafil, Sildenafil citrate 20 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 9 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Sildenafil	Sildenafil citrate 25 mg/1	Tablet, Film coatedOral	Jubilant Cadista Pharmaceuticals Inc.	59746-434	59746-0434-0359746-0434-0459746-0434-05+2 more
Sildenafil	Sildenafil citrate 50 mg/1	Tablet, Film coatedOral	Jubilant Cadista Pharmaceuticals Inc.	59746-435	59746-0435-0159746-0435-0359746-0435-04+3 more
Sildenafil	Sildenafil citrate 100 mg/1	Tablet, Film coatedOral	Jubilant Cadista Pharmaceuticals Inc.	59746-436	59746-0436-0159746-0436-0359746-0436-04+3 more
Sildenafil	Sildenafil citrate 20 mg/1	TabletOral	REMEDYREPACK INC.	70518-4596	70518-4596-00
Sildenafilsildenafil citrate	Sildenafil citrate 25 mg/1	FilmOral	Yaral Pharma Inc.	82347-0205	82347-0205-0482347-0205-0582347-0205-06
Sildenafilsildenafil citrate	Sildenafil citrate 50 mg/1	FilmOral	Yaral Pharma Inc.	82347-0210	82347-0210-0482347-0210-0582347-0210-06
Sildenafilsildenafil citrate	Sildenafil citrate 75 mg/1	FilmOral	Yaral Pharma Inc.	82347-0215	82347-0215-0482347-0215-0582347-0215-06
Sildenafilsildenafil citrate	Sildenafil citrate 100 mg/1	FilmOral	Yaral Pharma Inc.	82347-0220	82347-0220-0482347-0220-0582347-0220-06
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-987	51407-0987-90
Sildenafil	Sildenafil citrate 20 mg/1	TabletOral	AvKARE	42291-937	42291-0937-90

All 151 Sildenafil NDCs

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	NuCare Pharmaceuticals,Inc.	68071-5115
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4517
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1005
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	BluePoint Laboratories	68001-597
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-2072
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-813
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-061
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-121
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-788
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	BluePoint Laboratories	68001-363
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-536