NDC codes

FDA NDC Directory
Product NDC (as listed)16714-101Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0101Add 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
16714-101-021671401010260 TABLET in 1 BOTTLE (16714-101-02)Marketed from Dec 20, 2010
16714-101-0516714010105500 TABLET in 1 BOTTLE (16714-101-05)Marketed from Dec 20, 2010

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
Northstar RxLLCNDC labeler code 16714
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079072
Marketing start
Marketing end
Other FDA classes
Fibric Acids (Chemical structure)Peroxisome Proliferator-activated Receptor alpha Agonists (Mechanism)
Identifiers
Product ID 16714-101_ff9c9bd0-e2a2-4e38-aa8b-16d215d36450SPL ID ff9c9bd0-e2a2-4e38-aa8b-16d215d36450SPL set ID 75cac02c-56e3-4dfe-b1e2-4ce166b28833RxCUI 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

N416714010102 followed by a unit qualifier and the quantity

Package 16714-0101-02. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Gemfibrozil Tablets 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 trig…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16714-101

What is NDC 16714-101?
16714-101 is the product NDC for Gemfibrozil, Gemfibrozil 600 mg/1 tablet, listed with the FDA by Northstar RxLLC. It has 2 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?
Northstar RxLLC, NDC labeler code 16714. 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?
41 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 42 Gemfibrozil NDCs

Other NDCs under ANDA 079072

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

FDA NDC Directory listings under ANDA 079072
ProductStrengthForm · routeLabelerProduct NDC
GemfibrozilGemfibrozil 600 mg/1TabletOralA-S Medication Solutions50090-6913
GemfibrozilGemfibrozil 600 mg/1TabletOralA-S Medication Solutions50090-6939

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