What is NDC 71610-554?

71610-554 is the product NDC for Metformin hydrochloride, Metformin hydrochloride 500 mg/1 tablet, extended release, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 7 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Metformin hydrochloride?

366 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Metformin hydrochloride NDC 71610-554

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-554Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0554Add 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
71610-554-30	7161005543071610055430	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-30)Marketed from May 12, 2021
71610-554-53	7161005545371610055453	60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-53)Marketed from Jan 31, 2022
71610-554-60	7161005546071610055460	90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-60)Marketed from May 12, 2021
71610-554-70	7161005547071610055470	120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-70)Marketed from Jun 9, 2021
71610-554-80	7161005548071610055480	180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-80)Marketed from Jan 18, 2022
71610-554-92	7161005549271610055492	270 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-92)Marketed from Jun 18, 2021
71610-554-94	7161005549471610055494	360 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-94)Marketed from Aug 18, 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, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207427
Marketing start: Jul 17, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 71610-554_91ab7bd9-ef80-437c-967b-3f11991c2139SPL ID 91ab7bd9-ef80-437c-967b-3f11991c2139SPL set ID 5e5fb10b-b874-43c9-9424-9080b9e866c8RxCUI 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

N471610055430 followed by a unit qualifier and the quantity

Package 71610-0554-30. 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 Feb 22, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Metformin Hydrochloride Extended-release Tablets 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)

About NDC 71610-554

What is NDC 71610-554?: 71610-554 is the product NDC for Metformin hydrochloride, Metformin hydrochloride 500 mg/1 tablet, extended release, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 7 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Metformin hydrochloride.
What is the active ingredient?: Metformin hydrochloride.
Who is the labeler?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Metformin hydrochloride?: 366 other product NDCs are listed under this name. See all 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 Metformin hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4781	70518-4781-00
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Marlex Pharmaceuticals, Inc.	10135-823	10135-0823-0510135-0823-1010135-0823-30+5 more
Metformin Hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	Marlex Pharmaceuticals, Inc.	10135-824	10135-0824-0510135-0824-1010135-0824-90
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4185	68788-4185-0168788-4185-0368788-4185-06+3 more
Metformin Hydrochloride	Metformin hydrochloride 625 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-588	50228-0588-0550228-0588-30
Metformin Hydrochloride	Metformin hydrochloride 750 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-589	50228-0589-0550228-0589-30
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4710	70518-4710-0070518-4710-02
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	REMEDYREPACK INC.	70518-4698	70518-4698-00
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0591	80425-0591-0180425-0591-0280425-0591-03+1 more
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-054	87441-0054-01

All 367 Metformin hydrochloride NDCs

Other NDCs under ANDA 207427

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

FDA NDC Directory listings under ANDA 207427
Product	Strength	Form · route	Labeler	Product NDC
Metformin hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-587
Metformin hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-858
Metformin hydrochloride ERmetformin hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-867
Metformin hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	PD-Rx Pharmaceuticals, Inc.	72789-105
Metformin hydrochloride ERmetformin hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	PD-Rx Pharmaceuticals, Inc.	72789-106
Metformin hydrochloride ERmetformin hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-666
Metformin hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	AvKARE	42291-825
Metformin hydrochloride ERmetformin hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	AvKARE	42291-824
Metformin hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	UNICHEM PHARMACEUTICALS (USA), INC.	76385-128
Metformin hydrochloride ERmetformin hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	UNICHEM PHARMACEUTICALS (USA), INC.	76385-129