NDC codes

FDA NDC Directory
Product NDC (as listed)68382-186Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68382-0186Add 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
68382-186-016838201860168382018601100 TABLET, FILM COATED in 1 BOTTLE (68382-186-01)Marketed from May 5, 2016
68382-186-1068382018610683820186101000 TABLET, FILM COATED in 1 BOTTLE (68382-186-10)Marketed from May 5, 2016
68382-186-16683820186166838201861690 TABLET, FILM COATED in 1 BOTTLE (68382-186-16)Marketed from May 5, 2016
68382-186-77683820186776838201867710 BLISTER PACK in 1 CARTON (68382-186-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-186-30)Marketed from May 5, 2016

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

Generic name (nonproprietary)
glipizide and metformin hydrochloride
Active ingredients
Glipizide — 5 mg/1Metformin hydrochloride — 500 mg/1
Dosage form
Tablet, Film coated
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 078905
Marketing start
Listing expires
Other FDA classes
Biguanides (Chemical structure)Sulfonylurea Compounds (Chemical structure)
Identifiers
Product ID 68382-186_e66df8de-b76f-4812-9d00-9448cb378858SPL ID e66df8de-b76f-4812-9d00-9448cb378858SPL set ID 1b18b903-eb52-4d08-b4a5-f984957eb116RxCUI 861731, 861736, 861740UNII 786Z46389E, X7WDT95N5CUPC 0368382184016
Pharmacologic class
Biguanide; Sulfonylurea

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

N468382018601 followed by a unit qualifier and the quantity

Package 68382-0186-01. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Glipizide and metformin hydrochloride tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68382-186

What is NDC 68382-186?
68382-186 is the product NDC for Glipizide and Metformin Hydrochloride, Glipizide 5 mg/1; Metformin hydrochloride 500 mg/1 tablet, film coated, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Glipizide and Metformin Hydrochloride.
What is the active ingredient?
Glipizide, Metformin hydrochloride.
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 Glipizide and Metformin Hydrochloride?
13 other product NDCs are listed under this name. See all Glipizide and Metformin Hydrochloride 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 Glipizide and Metformin Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Glipizide and Metformin HydrochlorideGlipizide 5 mg/1; Metformin hydrochloride 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-037370518-0373-0070518-0373-01
Glipizide and Metformin HydrochlorideGlipizide 2.5 mg/1; Metformin hydrochloride 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-249250090-2492-00
Glipizide and Metformin HydrochlorideGlipizide 5 mg/1; Metformin hydrochloride 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-255650090-2556-00
Glipizide and Metformin HydrochlorideGlipizide 2.5 mg/1; Metformin hydrochloride 250 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-65965841-0659-0165841-0659-1065841-0659-16+1 more
Glipizide and Metformin HydrochlorideGlipizide 2.5 mg/1; Metformin hydrochloride 500 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-66065841-0660-0165841-0660-1065841-0660-16+1 more
Glipizide and Metformin HydrochlorideGlipizide 5 mg/1; Metformin hydrochloride 500 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-66165841-0661-0165841-0661-1065841-0661-16+1 more
Glipizide and Metformin HydrochlorideGlipizide 2.5 mg/1; Metformin hydrochloride 250 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.68382-18468382-0184-0168382-0184-1068382-0184-16+1 more
Glipizide and Metformin HydrochlorideGlipizide 2.5 mg/1; Metformin hydrochloride 500 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.68382-18568382-0185-0168382-0185-1068382-0185-16+1 more
Glipizide and Metformin HydrochlorideGlipizide 2.5 mg/1; Metformin hydrochloride 500 mg/1Tablet, Film coatedOralAvKARE42291-30542291-0305-01
Glipizide and Metformin HydrochlorideGlipizide 5 mg/1; Metformin hydrochloride 500 mg/1Tablet, Film coatedOralAvKARE42291-30642291-0306-01

All 14 Glipizide and Metformin Hydrochloride NDCs

Other NDCs under ANDA 078905

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

FDA NDC Directory listings under ANDA 078905
ProductStrengthForm · routeLabelerProduct NDC
Glipizide and Metformin HydrochlorideGlipizide 2.5 mg/1; Metformin hydrochloride 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2492
Glipizide and Metformin HydrochlorideGlipizide 5 mg/1; Metformin hydrochloride 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2556
Glipizide and Metformin HydrochlorideGlipizide 2.5 mg/1; Metformin hydrochloride 250 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-659
Glipizide and Metformin HydrochlorideGlipizide 2.5 mg/1; Metformin hydrochloride 500 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-660
Glipizide and Metformin HydrochlorideGlipizide 5 mg/1; Metformin hydrochloride 500 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-661
Glipizide and Metformin HydrochlorideGlipizide 2.5 mg/1; Metformin hydrochloride 250 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.68382-184
Glipizide and Metformin HydrochlorideGlipizide 2.5 mg/1; Metformin hydrochloride 500 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.68382-185

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