What is NDC 68382-553?

68382-553 is the product NDC for Gemfibrozil, Gemfibrozil 600 mg/1 tablet, listed with the FDA by Zydus Pharmaceuticals (USA) Inc.. It has 7 package NDCs, shown above in 10- and 11-digit form.

Zydus Pharmaceuticals (USA) Inc., NDC labeler code 68382. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Gemfibrozil NDC 68382-553 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-553Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0553Add 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
68382-553-01	68382055301	100 TABLET in 1 BOTTLE (68382-553-01)Marketed from Jan 15, 2019
68382-553-05	68382055305	500 TABLET in 1 BOTTLE (68382-553-05)Marketed from Jan 15, 2019
68382-553-06	68382055306	30 TABLET in 1 BOTTLE (68382-553-06)Marketed from Jan 15, 2019
68382-553-10	68382055310	1000 TABLET in 1 BOTTLE (68382-553-10)Marketed from Jan 15, 2019
68382-553-14	68382055314	60 TABLET in 1 BOTTLE (68382-553-14)Marketed from Jan 15, 2019
68382-553-16	68382055316	90 TABLET in 1 BOTTLE (68382-553-16)Marketed from Jan 15, 2019
68382-553-30	68382055330	10 BLISTER PACK in 1 CARTON (68382-553-30) / 10 TABLET in 1 BLISTER PACKMarketed from Jan 15, 2019

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: Zydus Pharmaceuticals (USA) Inc.NDC labeler code 68382
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204189
Marketing start: Jan 15, 2019
Listing expires: Dec 31, 2026
Other FDA classes: PPAR alpha (Chemical structure)Peroxisome Proliferator-activated Receptor alpha Agonists (Mechanism)
Identifiers: Product ID 68382-553_9c4294b2-eee2-42d7-b260-6fc2e7e28833SPL ID 9c4294b2-eee2-42d7-b260-6fc2e7e28833SPL set ID 556945e8-4100-4538-bcba-af5b2f13a7e8RxCUI 310459UNII Q8X02027X3UPC 0368382553065
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

N468382055301 followed by a unit qualifier and the quantity

Package 68382-0553-01. 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 Nov 8, 2024.

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 68382-553

What is NDC 68382-553?: 68382-553 is the product NDC for Gemfibrozil, Gemfibrozil 600 mg/1 tablet, listed with the FDA by Zydus Pharmaceuticals (USA) Inc.. 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 Pharmaceuticals (USA) Inc., NDC labeler code 68382. 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
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	Camber Pharmaceuticals, Inc.	31722-128	31722-0128-0531722-0128-60
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	A-S Medication Solutions	50090-7809	50090-7809-00
Gemfibrozil	Gemfibrozil 600 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-2387	68071-2387-0368071-2387-0668071-2387-08
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	Aphena Pharma Solutions - Tennessee, LLC	71610-601	71610-0601-5371610-0601-60

All 42 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 Lifesciences Limited	70771-1431
Gemfibrozil	Gemfibrozil 600 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-066