What is NDC 70771-1431?

70771-1431 is the product NDC for Gemfibrozil, Gemfibrozil 600 mg/1 tablet, listed with the FDA by Zydus Lifesciences Limited. It has 7 package NDCs, shown above in 10- and 11-digit form.

Zydus Lifesciences Limited, NDC labeler code 70771. 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 70771-1431 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70771-1431Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70771-1431Add 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
70771-1431-0	70771143100	1000 TABLET in 1 BOTTLE (70771-1431-0)Marketed from Feb 21, 2020
70771-1431-1	70771143101	100 TABLET in 1 BOTTLE (70771-1431-1)Marketed from Feb 21, 2020
70771-1431-3	70771143103	30 TABLET in 1 BOTTLE (70771-1431-3)Marketed from Feb 21, 2020
70771-1431-4	70771143104	10 BLISTER PACK in 1 CARTON (70771-1431-4) / 10 TABLET in 1 BLISTER PACKMarketed from Feb 21, 2020
70771-1431-5	70771143105	500 TABLET in 1 BOTTLE (70771-1431-5)Marketed from Feb 21, 2020
70771-1431-6	70771143106	60 TABLET in 1 BOTTLE (70771-1431-6)Marketed from Feb 21, 2020
70771-1431-9	70771143109	90 TABLET in 1 BOTTLE (70771-1431-9)Marketed from Feb 21, 2020

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: Zydus Lifesciences LimitedNDC labeler code 70771
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204189
Marketing start: Feb 21, 2020
Listing expires: Dec 31, 2026
Other FDA classes: PPAR alpha (Chemical structure)Peroxisome Proliferator-activated Receptor alpha Agonists (Mechanism)
Identifiers: Product ID 70771-1431_2f3cb828-6ff1-428d-99c7-edb835d25d10SPL ID 2f3cb828-6ff1-428d-99c7-edb835d25d10SPL set ID e6bc1a4f-2a4f-4fdf-8084-488ec8b8b7abRxCUI 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

N470771143100 followed by a unit qualifier and the quantity

Package 70771-1431-00. 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 Dec 15, 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 tablets therapy may be considered for those subje…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70771-1431

What is NDC 70771-1431?: 70771-1431 is the product NDC for Gemfibrozil, Gemfibrozil 600 mg/1 tablet, listed with the FDA by Zydus Lifesciences Limited. It has 7 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?: Zydus Lifesciences Limited, NDC labeler code 70771. 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 204189

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

FDA NDC Directory listings under ANDA 204189
Product	Strength	Form · route	Labeler	Product NDC
Gemfibrozil	Gemfibrozil 600 mg/1	TabletOral	Zydus Pharmaceuticals (USA) Inc.	68382-553
Gemfibrozil	Gemfibrozil 600 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-066