NDC codes

FDA NDC Directory
Product NDC (as listed)68071-1733Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-1733Add 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
68071-1733-6680711733066807117330660 TABLET in 1 BOTTLE (68071-1733-6)Marketed from Sep 14, 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
NuCare Pharmaceuticals,Inc.NDC labeler code 68071
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077836
Marketing start
Listing expires
Other FDA classes
PPAR alpha (Chemical structure)Peroxisome Proliferator-activated Receptor alpha Agonists (Mechanism)
Identifiers
Product ID 68071-1733_2a34680f-3f93-1d85-e063-6294a90a79f3SPL ID 2a34680f-3f93-1d85-e063-6294a90a79f3SPL set ID 592811f2-e231-6a58-e053-2991aa0a69a9RxCUI 310459UNII Q8X02027X3UPC 0368071173369
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

N468071173306 followed by a unit qualifier and the quantity

Package 68071-1733-06. 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, 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 68071-1733

What is NDC 68071-1733?
68071-1733 is the product NDC for Gemfibrozil, Gemfibrozil 600 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 1 package NDC, 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?
NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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/1TabletOralNorthwind Health Company, LLC51655-143
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/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

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in