What is NDC 71209-008?

71209-008 is the product NDC for Gemfibrozil, Gemfibrozil 600 mg/1 tablet, listed with the FDA by Cadila Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

Cadila Pharmaceuticals Limited, NDC labeler code 71209. 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 71209-008 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71209-008Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71209-0008Add 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
71209-008-03	71209000803	60 TABLET in 1 BOTTLE (71209-008-03)Marketed from Oct 17, 2018
71209-008-08	71209000808	180 TABLET in 1 BOTTLE (71209-008-08)Marketed from Oct 17, 2018
71209-008-10	71209000810	500 TABLET in 1 BOTTLE (71209-008-10)Marketed from Oct 17, 2018

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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: Cadila Pharmaceuticals LimitedNDC labeler code 71209
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203266
Marketing start: Jun 17, 2016
Listing expires: Dec 31, 2026
Other FDA classes: PPAR alpha (Chemical structure)Peroxisome Proliferator-activated Receptor alpha Agonists (Mechanism)
Identifiers: Product ID 71209-008_b3071718-e27b-4690-88dd-fc58a4fcbf41SPL ID b3071718-e27b-4690-88dd-fc58a4fcbf41SPL set ID 0b50849a-66b6-4e8f-9f45-5425a875d366RxCUI 310459UNII Q8X02027X3UPC 0371209008082, 0371209008105, 0371209008037
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

N471209000803 followed by a unit qualifier and the quantity

Package 71209-0008-03. 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 27, 2022.

Indications (excerpt from the label)

INDICATIONS & 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 wit…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71209-008

What is NDC 71209-008?: 71209-008 is the product NDC for Gemfibrozil, Gemfibrozil 600 mg/1 tablet, listed with the FDA by Cadila Pharmaceuticals Limited. It has 3 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?: Cadila Pharmaceuticals Limited, NDC labeler code 71209. 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 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	Bryant Ranch Prepack	71335-1902