Glumetza (metformin hydrochloride) NDC 68012-004

NDC codes

FDA NDC Directory

Product NDC (as listed)68012-004Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68012-0004Add 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	Copy
68012-004-50	68012000450	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68012-004-50)Marketed from Mar 20, 2018

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): Glumetza
Generic name (nonproprietary): metformin hydrochloride
Active ingredients: Metformin hydrochloride — 500 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Santarus, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021748
Marketing start: Mar 20, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 68012-004_8aee004e-3e08-4791-a09a-cb17bb5230caSPL ID 8aee004e-3e08-4791-a09a-cb17bb5230ca
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

N468012000450 followed by a unit qualifier and the quantity

Package 68012-0004-50. 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

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under NDA 021748

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

FDA NDC Directory listings under NDA 021748
Product	Strength	Form · route	Labeler	Product NDC
Metformin hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Film coated, Extended releaseOral	Oceanside Pharmaceuticals	68682-021
Metformin hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Oceanside Pharmaceuticals	68682-018
Glumetzametformin hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Film coated, Extended releaseOral	Santarus, Inc.	68012-002
Glumetzametformin hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Santarus, Inc.	68012-003