What is NDC 72189-635?

72189-635 is the product NDC for Metformin HCL, Metformin hydrochloride 1000 mg/1 tablet, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.

Direct_Rx, NDC labeler code 72189. 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 HCL?

32 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Metformin HCL NDC 72189-635 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-635Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0635Add 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
72189-635-82	7218906358272189063582	180 TABLET in 1 BOTTLE (72189-635-82)Marketed from Jul 25, 2025

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 HCL
Generic name (nonproprietary): metformin hcl
Active ingredients: Metformin hydrochloride — 1000 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213320
Marketing start: Jul 25, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 72189-635_3ac4e864-4b8b-13b1-e063-6294a90ada66SPL ID 3ac4e864-4b8b-13b1-e063-6294a90ada66SPL set ID 3ac4e864-4b8a-13b1-e063-6294a90ada66RxCUI 861004UNII 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

N472189063582 followed by a unit qualifier and the quantity

Package 72189-0635-82. 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 25, 2025. 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.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-635

What is NDC 72189-635?: 72189-635 is the product NDC for Metformin HCL, Metformin hydrochloride 1000 mg/1 tablet, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Metformin HCL.
What is the active ingredient?: Metformin hydrochloride.
Who is the labeler?: Direct_Rx, NDC labeler code 72189. 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 HCL?: 32 other product NDCs are listed under this name. See all Metformin HCL 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 HCL NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Metformin HCl	Metformin hydrochloride 500 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-056	87441-0056-01
Metformin HCl	Metformin hydrochloride 1000 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-055	87441-0055-01
Metformin HCL	Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-658	72189-0658-3072189-0658-8272189-0658-90
Metformin HCl	Metformin hydrochloride 850 mg/1	TabletOral	REMEDYREPACK INC.	70518-4479	70518-4479-0070518-4479-01
Metformin HCL	Metformin hydrochloride 500 mg/1	TabletOral	Direct_Rx	72189-617	72189-0617-3072189-0617-82
Metformin HCl	Metformin hydrochloride 1000 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0435	80425-0435-0180425-0435-0280425-0435-03+1 more
Metformin HCl	Metformin hydrochloride 500 mg/1	TabletOral	Northwind Health Company, LLC	82868-049	82868-0049-6082868-0049-9082868-0049-98
Metformin HCl	Metformin hydrochloride 500 mg/1	TabletOral	QPharma, Inc.	42708-009	42708-0009-60
Metformin HCl	Metformin hydrochloride 1000 mg/1	TabletOral	QPharma, Inc.	42708-018	42708-0018-30
Metformin HCl	Metformin hydrochloride 850 mg/1	TabletOral	A-S Medication Solutions	50090-3050	50090-3050-0050090-3050-0250090-3050-04+1 more

All 33 Metformin HCL NDCs

Other NDCs under ANDA 213320

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

FDA NDC Directory listings under ANDA 213320
Product	Strength	Form · route	Labeler	Product NDC
Metformin HCL	Metformin hydrochloride 500 mg/1	TabletOral	Direct_Rx	72189-617
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-841
Metformin Hydrochloride	Metformin hydrochloride 850 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-842
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-843
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	QPharma Inc	42708-202
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	QPharma,Inc.	42708-203
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7877
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7878
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-8041
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-8043
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	Coupler LLC	67046-1516
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-930
Metformin Hydrochloride	Metformin hydrochloride 850 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-931
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-932
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3518
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3526
Metformin Hydrochloride	Metformin hydrochloride 850 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3531
Metformin Hydrochloride	Metformin hydrochloride 850 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3575
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3739
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticcals,Inc.	68071-5306

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