NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2694Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2694Add 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
71335-2694-17133526940171335269401100 TABLET in 1 BOTTLE (71335-2694-1)Marketed from Sep 24, 2025
71335-2694-2713352694027133526940230 TABLET in 1 BOTTLE (71335-2694-2)Marketed from Sep 24, 2025
71335-2694-3713352694037133526940360 TABLET in 1 BOTTLE (71335-2694-3)Marketed from Sep 24, 2025
71335-2694-4713352694047133526940490 TABLET in 1 BOTTLE (71335-2694-4)Marketed from Sep 24, 2025
71335-2694-57133526940571335269405180 TABLET in 1 BOTTLE (71335-2694-5)Marketed from Sep 24, 2025

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)
glyburide-metformin hydrochloride
Generic name (nonproprietary)
glyburide-metformin hydrochloride
Active ingredients
Glyburide — 2.5 mg/1Metformin hydrochloride — 500 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079009
Marketing start
Listing expires
Other FDA classes
Biguanides (Chemical structure)Sulfonylurea Compounds (Chemical structure)
Identifiers
Product ID 71335-2694_a112dbe1-3324-4e92-8d0f-7d0d3951c37dSPL ID a112dbe1-3324-4e92-8d0f-7d0d3951c37dSPL set ID a086cc29-cb5d-40d0-a57d-8e91f1aa9158RxCUI 861748UNII SX6K58TVWC, 786Z46389E
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

N471335269401 followed by a unit qualifier and the quantity

Package 71335-2694-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Glyburide and metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glyburide and metformin hydrochloride tablets are a combination of glyburide, a sulfonylurea, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-2694

What is NDC 71335-2694?
71335-2694 is the product NDC for glyburide-metformin hydrochloride, Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
glyburide-metformin hydrochloride.
What is the active ingredient?
Glyburide, Metformin hydrochloride.
Who is the labeler?
Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for glyburide-metformin hydrochloride?
8 other product NDCs are listed under this name. See all glyburide-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 glyburide-metformin hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
glyburide-metformin hydrochlorideGlyburide 5 mg/1; Metformin hydrochloride 500 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-879168788-8791-0168788-8791-0368788-8791-06+2 more
glyburide-metformin hydrochlorideGlyburide 1.25 mg/1; Metformin hydrochloride 250 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-23323155-0233-0123155-0233-0523155-0233-10
glyburide-metformin hydrochlorideGlyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-23423155-0234-0123155-0234-0523155-0234-10
glyburide-metformin hydrochlorideGlyburide 5 mg/1; Metformin hydrochloride 500 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-23523155-0235-0123155-0235-0523155-0235-10
glyburide-metformin hydrochlorideGlyburide 5 mg/1; Metformin hydrochloride 500 mg/1TabletOralA-S Medication Solutions50090-751450090-7514-0050090-7514-0250090-7514-03+1 more
glyburide-metformin hydrochlorideGlyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1TabletOralA-S Medication Solutions50090-781450090-7814-0050090-7814-02
glyburide-metformin hydrochlorideGlyburide 5 mg/1; Metformin hydrochloride 500 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-395068071-3950-03
glyburide-metformin hydrochlorideGlyburide 5 mg/1; Metformin hydrochloride 500 mg/1TabletOralBryant Ranch Prepack71335-250871335-2508-0171335-2508-0371335-2508-04+4 more

Other NDCs under ANDA 079009

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

FDA NDC Directory listings under ANDA 079009
ProductStrengthForm · routeLabelerProduct NDC
glyburide-metformin hydrochlorideGlyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1TabletOralA-S Medication Solutions50090-7814
glyburide-metformin hydrochlorideGlyburide 5 mg/1; Metformin hydrochloride 500 mg/1TabletOralBryant Ranch Prepack71335-2508
glyburide-metformin hydrochlorideGlyburide 5 mg/1; Metformin hydrochloride 500 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8791
glyburide-metformin hydrochlorideGlyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-234
glyburide-metformin hydrochlorideGlyburide 5 mg/1; Metformin hydrochloride 500 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3950
glyburide-metformin hydrochlorideGlyburide 1.25 mg/1; Metformin hydrochloride 250 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-233
glyburide-metformin hydrochlorideGlyburide 5 mg/1; Metformin hydrochloride 500 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-235
glyburide-metformin hydrochlorideGlyburide 5 mg/1; Metformin hydrochloride 500 mg/1TabletOralA-S Medication Solutions50090-7514

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