What is NDC 71335-0051?

71335-0051 is the product NDC for Gemfibrozil, Gemfibrozil 600 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 5 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 Gemfibrozil?

42 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Gemfibrozil NDC 71335-0051 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-0051Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-0051Add 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
71335-0051-1	71335005101	60 TABLET in 1 BOTTLE (71335-0051-1)Marketed from Oct 3, 2017
71335-0051-2	71335005102	30 TABLET in 1 BOTTLE (71335-0051-2)Marketed from Oct 3, 2017
71335-0051-3	71335005103	100 TABLET in 1 BOTTLE (71335-0051-3)Marketed from Oct 3, 2017
71335-0051-4	71335005104	90 TABLET in 1 BOTTLE (71335-0051-4)Marketed from Oct 3, 2017
71335-0051-5	71335005105	180 TABLET in 1 BOTTLE (71335-0051-5)Marketed from Oct 3, 2017

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): Gemfibrozil
Generic name (nonproprietary): gemfibrozil
Active ingredients: Gemfibrozil — 600 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 71335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078012
Marketing start: Mar 23, 2017
Listing expires: Dec 31, 2026
Other FDA classes: PPAR alpha (Chemical structure)Peroxisome Proliferator-activated Receptor alpha Agonists (Mechanism)
Identifiers: Product ID 71335-0051_cc153611-a05f-4d96-8132-1b7da12f24fbSPL ID cc153611-a05f-4d96-8132-1b7da12f24fbSPL set ID 2cb2de4d-8261-46d8-ae63-c572fdc887d4RxCUI 310459UNII Q8X02027X3
Pharmacologic class: Peroxisome Proliferator Receptor alpha Agonist

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

N471335005101 followed by a unit qualifier and the quantity

Package 71335-0051-01. 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 Aug 26, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for: 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects w…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-0051

What is NDC 71335-0051?: 71335-0051 is the product NDC for Gemfibrozil, Gemfibrozil 600 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Gemfibrozil.
What is the active ingredient?: Gemfibrozil.
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 Gemfibrozil?: 42 other product NDCs are listed under this name. See all Gemfibrozil 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 Gemfibrozil NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Gemfibrozil	Gemfibrozil 600 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4764	70518-4764-00
Gemfibrozil	Gemfibrozil 600 mg/1	TabletOral	Coupler LLC	67046-0233	67046-0233-03
Gemfibrozil	Gemfibrozil 600 mg/1	TabletOral	REMEDYREPACK INC.	70518-4305	70518-4305-00
Gemfibrozil	Gemfibrozil 600 mg/1	TabletOral	Preferred Pharmaceuticals, Inc.	68788-7964	68788-7964-0368788-7964-0668788-7964-09
Gemfibrozil	Gemfibrozil 600 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-601	71610-0601-5371610-0601-60
Gemfibrozil	Gemfibrozil 600 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-2387	68071-2387-0368071-2387-0668071-2387-08
Gemfibrozil	Gemfibrozil 600 mg/1	TabletOral	XLCare Pharmaceuticals, Inc.	72865-186	72865-0186-0572865-0186-1872865-0186-60
Gemfibrozil	Gemfibrozil 600 mg/1	TabletOral	A-S Medication Solutions	50090-7809	50090-7809-00
Gemfibrozil	Gemfibrozil 600 mg/1	TabletOral	Bryant Ranch Prepack	71335-1996	71335-1996-0171335-1996-0271335-1996-03+2 more
Gemfibrozil	Gemfibrozil 600 mg/1	TabletOral	Bryant Ranch Prepack	72162-2119	72162-2119-06

All 43 Gemfibrozil NDCs

Other NDCs under ANDA 078012

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

FDA NDC Directory listings under ANDA 078012
Product	Strength	Form · route	Labeler	Product NDC
Gemfibrozil	Gemfibrozil 600 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-824