NDC codes

FDA NDC Directory
Product NDC (as listed)51655-143Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51655-0143Add 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 NDC11-digit (billing)PackageCopy
51655-143-25516550143255165501432560 TABLET in 1 BOTTLE, PLASTIC (51655-143-25)Marketed from Dec 6, 2022
51655-143-26516550143265165501432690 TABLET in 1 BOTTLE, PLASTIC (51655-143-26)Marketed from Aug 14, 2017
51655-143-52516550143525165501435230 TABLET in 1 BOTTLE, PLASTIC (51655-143-52)Marketed from Nov 13, 2017
51655-143-835165501438351655014383180 TABLET in 1 BOTTLE, PLASTIC (51655-143-83)Marketed from Aug 14, 2017

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
Northwind Health Company, LLCNDC labeler code 51655
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077836
Marketing start
Listing expires
Other FDA classes
Fibric Acids (Chemical structure)Peroxisome Proliferator-activated Receptor alpha Agonists (Mechanism)
Identifiers
Product ID 51655-143_48c3ec58-2075-5cc3-e063-6394a90aaffaSPL ID 48c3ec58-2075-5cc3-e063-6394a90aaffaSPL set ID a95264ab-eb86-7699-e053-2995a90a3d1fRxCUI 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

N451655014325 followed by a unit qualifier and the quantity

Package 51655-0143-25. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Gemfibrozil Tablets 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 2,000 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 1,000 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 51655-143

What is NDC 51655-143?
51655-143 is the product NDC for Gemfibrozil, Gemfibrozil 600 mg/1 tablet, listed with the FDA by Northwind Health Company, LLC. It has 4 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?
Northwind Health Company, LLC, NDC labeler code 51655. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
GemfibrozilGemfibrozil 600 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-476470518-4764-00
GemfibrozilGemfibrozil 600 mg/1TabletOralCoupler LLC67046-023367046-0233-03
GemfibrozilGemfibrozil 600 mg/1TabletOralREMEDYREPACK INC.70518-430570518-4305-00
GemfibrozilGemfibrozil 600 mg/1TabletOralPreferred Pharmaceuticals, Inc.68788-796468788-7964-0368788-7964-0668788-7964-09
GemfibrozilGemfibrozil 600 mg/1TabletOralCamber Pharmaceuticals, Inc.31722-12831722-0128-0531722-0128-60
GemfibrozilGemfibrozil 600 mg/1TabletOralA-S Medication Solutions50090-580850090-5808-0050090-5808-0250090-5808-03+1 more
GemfibrozilGemfibrozil 600 mg/1TabletOralA-S Medication Solutions50090-780950090-7809-00
GemfibrozilGemfibrozil 600 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-238768071-2387-0368071-2387-0668071-2387-08
GemfibrozilGemfibrozil 600 mg/1TabletOralBryant Ranch Prepack71335-199671335-1996-0171335-1996-0271335-1996-03+2 more
GemfibrozilGemfibrozil 600 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-60171610-0601-5371610-0601-60

All 43 Gemfibrozil NDCs

Other NDCs under ANDA 077836

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

FDA NDC Directory listings under ANDA 077836
ProductStrengthForm · routeLabelerProduct NDC
GemfibrozilGemfibrozil 600 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-745
GemfibrozilGemfibrozil 600 mg/1TabletOralAvPAK50268-350
GemfibrozilGemfibrozil 600 mg/1TabletOralAmerican Health Packaging60687-224
GemfibrozilGemfibrozil 600 mg/1TabletOralProficient Rx LP63187-772
GemfibrozilGemfibrozil 600 mg/1TabletOralNuCare Pharmaceuticals, Inc.66267-436
GemfibrozilGemfibrozil 600 mg/1TabletOralCoupler LLC67046-0233
GemfibrozilGemfibrozil 600 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-1733
GemfibrozilGemfibrozil 600 mg/1TabletOralCipla USA Inc.69097-821
GemfibrozilGemfibrozil 600 mg/1TabletOralREMEDYREPACK INC.70518-1563
GemfibrozilGemfibrozil 600 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-107
GemfibrozilGemfibrozil 600 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-200
GemfibrozilGemfibrozil 600 mg/1Tablet, Film coatedOralExelan Pharmaceuticals, Inc.76282-225

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