Metformin Hydrochloride Extended Release NDC 68071-3111

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-3111Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-3111Add 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
68071-3111-2	68071311102	120 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-3111-2)Marketed from Mar 9, 2017
68071-3111-3	68071311103	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-3111-3)Marketed from Mar 9, 2017
68071-3111-6	68071311106	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-3111-6)Marketed from Mar 9, 2017
68071-3111-8	68071311108	180 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-3111-8)Marketed from Mar 9, 2017
68071-3111-9	68071311109	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-3111-9)Marketed from Mar 9, 2017

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): Metformin Hydrochloride Extended Release
Generic name (nonproprietary): metformin hydrochloride
Active ingredients: Metformin hydrochloride — 500 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: NuCare Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090295
Marketing start: May 12, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 68071-3111_1d9eaa76-848f-a471-e063-6394a90aef30SPL ID 1d9eaa76-848f-a471-e063-6394a90aef30SPL set ID 4a53ea53-3052-614b-e054-00144ff8d46cRxCUI 860975UNII 786Z46389EUPC 0368071311198
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

N468071311102 followed by a unit qualifier and the quantity

Package 68071-3111-02. 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 Jul 19, 2024.

Indications (excerpt from the label)

Metformin Hydrochloride Extended-Release Tablets, USP is 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)

Other NDCs under ANDA 090295

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

FDA NDC Directory listings under ANDA 090295
Product	Strength	Form · route	Labeler	Product NDC
Metformin Hydrochloride Extended Releasemetformin hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	Proficient Rx LP	82804-148
Metformin Hydrochloride Extended Releasemetformin hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Northwind Health Company, LLC	51655-555
Metformin Hydrochloride Extended Releasemetformin hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	PD-Rx Pharmaceuticals, Inc.	43063-902
Metformin Hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	MARKSANS PHARMA LIMITED	25000-102
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	MARKSANS PHARMA LIMITED	25000-101
Metformin Hydrochloride Extended Releasemetformin hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	PD-Rx Pharmaceuticals, Inc.	72789-009
Metformin Hydrochloride Extended Releasemetformin hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	TIME CAP LABORATORIES, INC	49483-623
Metformin Hydrochloride Extended Releasemetformin hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-454
Metformin Hydrochloride Extended Releasemetformin hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	TIME CAP LABORATORIES, INC	49483-624
Metformin Hydrochloride Extended Releasemetformin hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-0889
Metformin Hydrochloride Extended Releasemetformin hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-0293
Metformin Hydrochloride Extended Releasemetformin hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	direct rx	72189-064