Metformin Hydrochloride NDC 71610-447

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-447Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0447Add 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
71610-447-30	71610044730	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-447-30)Marketed from Jul 24, 2020
71610-447-53	71610044753	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-447-53)Marketed from Jul 24, 2020
71610-447-60	71610044760	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-447-60)Marketed from Jul 24, 2020
71610-447-70	71610044770	120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-447-70)Marketed from Jul 24, 2020
71610-447-80	71610044780	180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-447-80)Marketed from Jul 24, 2020
71610-447-94	71610044794	360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-447-94)Marketed from Mar 11, 2021

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, Extended release
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077336
Marketing start: Feb 9, 2006
Listing expires: Dec 31, 2026
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 71610-447_f2b2e161-6f49-4a65-970e-017b5c4dcd74SPL ID f2b2e161-6f49-4a65-970e-017b5c4dcd74SPL set ID 439bb230-94d8-4522-ad79-5cce5fad965bRxCUI 860975UNII 786Z46389E
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

N471610044730 followed by a unit qualifier and the quantity

Package 71610-0447-30. 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 Apr 27, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

Metformin hydrochloride extended-release tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin hydrochloride is a biguanide indicated as an adjunct to diet and exe rcise to i m p rove gl yc e mic cont rol in adults with t ype 2 diabetes m ellitus. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077336

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

FDA NDC Directory listings under ANDA 077336
Product	Strength	Form · route	Labeler	Product NDC
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Sun Pharmaceutical Industries, Inc.	62756-142