What is NDC 71335-1902?

71335-1902 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 71335-1902 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-1902Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-1902Add 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
71335-1902-1	71335190201	60 TABLET in 1 BOTTLE (71335-1902-1)Marketed from Jul 13, 2021
71335-1902-2	71335190202	30 TABLET in 1 BOTTLE (71335-1902-2)Marketed from Aug 3, 2021
71335-1902-3	71335190203	100 TABLET in 1 BOTTLE (71335-1902-3)Marketed from Mar 10, 2022
71335-1902-4	71335190204	90 TABLET in 1 BOTTLE (71335-1902-4)Marketed from Mar 10, 2022
71335-1902-5	71335190205	180 TABLET in 1 BOTTLE (71335-1902-5)Marketed from Sep 13, 2021

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 203266
Marketing start: Feb 15, 2017
Listing expires: Dec 31, 2026
Other FDA classes: PPAR alpha (Chemical structure)Peroxisome Proliferator-activated Receptor alpha Agonists (Mechanism)
Identifiers: Product ID 71335-1902_be2e589c-9e89-462a-844a-d3617a68a8d3SPL ID be2e589c-9e89-462a-844a-d3617a68a8d3SPL set ID fe91d458-1877-4c2e-aa15-efd802e6741fRxCUI 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

N471335190201 followed by a unit qualifier and the quantity

Package 71335-1902-01. 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 Oct 24, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for: 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 with…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-1902

What is NDC 71335-1902?: 71335-1902 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	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
Gemfibrozil	Gemfibrozil 600 mg/1	TabletOral	A-S Medication Solutions	50090-5808	50090-5808-0050090-5808-0250090-5808-03+1 more
Gemfibrozil	Gemfibrozil 600 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-128	31722-0128-0531722-0128-60
Gemfibrozil	Gemfibrozil 600 mg/1	TabletOral	Proficient Rx LP	82804-221	82804-0221-90
Gemfibrozil	Gemfibrozil 600 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-601	71610-0601-5371610-0601-60

All 43 Gemfibrozil NDCs

Other NDCs under ANDA 203266

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

FDA NDC Directory listings under ANDA 203266
Product	Strength	Form · route	Labeler	Product NDC
Gemfibrozil	Gemfibrozil 600 mg/1	TabletOral	Cadila Pharmaceuticals Limited	71209-008