Prescription drug · ANDA

Metformin Hydrochloride NDC 69367-180

Metformin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · Westminster Pharmaceuticals, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)69367-180Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69367-0180Add 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
69367-180-0169367018001100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-180-01)Marketed from Nov 21, 2017
69367-180-0569367018005500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-180-05)Marketed from Nov 21, 2017
69367-180-10693670180101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-180-10)Marketed from Apr 21, 2020

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)
Metformin Hydrochloride
Generic name (nonproprietary)
metformin hydrochloride
Active ingredients
Metformin hydrochloride — 500 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203769
Marketing start
Marketing end
Other FDA classes
Biguanides (Chemical structure)
Identifiers
Product ID 69367-180_67a94e43-0280-4469-a2f1-35eced77f9a7SPL ID 67a94e43-0280-4469-a2f1-35eced77f9a7SPL set ID 836f3647-bfef-40d1-b475-c0d240241a67RxCUI 861004, 861007, 861010UNII 786Z46389EUPC 0369367182010, 0369367180016, 0369367181013
Pharmacologic class
Biguanide

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

N469367018001 followed by a unit qualifier and the quantity

Package 69367-0180-01. 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)

Metformin Hydrochloride Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203769

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

FDA NDC Directory listings under ANDA 203769
ProductStrengthForm · routeLabelerProduct NDC
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-1951
Metformin HydrochlorideMetformin hydrochloride 850 mg/1TabletOralScieGen Pharmaceuticals Inc50228-106
Metformin HydrochlorideMetformin hydrochloride 850 mg/1TabletOralBryant Ranch Prepack71335-1785
Metformin HydrochlorideMetformin hydrochloride 500 mg/1TabletOralScieGen Pharmaceuticals Inc50228-105
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1TabletOralScieGen Pharmaceuticals Inc50228-107
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralProficient Rx LP71205-884
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralProficient Rx LP71205-882
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralProficient Rx LP71205-883
Metformin HydrochlorideMetformin hydrochloride 500 mg/1TabletOralBryant Ranch Prepack71335-1834
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1TabletOralBryant Ranch Prepack63629-8504
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1TabletOralBryant Ranch Prepack71335-1833
Metformin HydrochlorideMetformin hydrochloride 850 mg/1TabletOralBryant Ranch Prepack71335-1835
Metformin HydrochlorideMetformin hydrochloride 850 mg/1TabletOralGolden State Medical Supply, Inc.60429-112
Metformin HydrochlorideMetformin hydrochloride 500 mg/1TabletOralGolden State Medical Supply, Inc.60429-111
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1TabletOralGolden State Medical Supply, Inc.60429-113
Metformin HydrochlorideMetformin hydrochloride 625 mg/1TabletOralMethod Pharmaceuticals, LLC.58657-726
Metformin HydrochlorideMetformin hydrochloride 750 mg/1TabletOralMethod Pharmaceuticals, LLC.58657-727
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1TabletOraldirect rx72189-220
Metformin HydrochlorideMetformin hydrochloride 500 mg/1TabletOralBryant Ranch Prepack72162-1522
Metformin HydrochlorideMetformin hydrochloride 500 mg/1TabletOraldirect rx72189-219

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Metformin Hydrochloride NDC 69367-180 | Med-Code