What is NDC 68788-8528?

68788-8528 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 850 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.

Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 68788-8528

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-8528Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-8528Add 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
68788-8528-1	6878885280168788852801	100 TABLET in 1 BOTTLE (68788-8528-1)Marketed from Oct 6, 2023
68788-8528-3	6878885280368788852803	30 TABLET in 1 BOTTLE (68788-8528-3)Marketed from Oct 6, 2023
68788-8528-6	6878885280668788852806	60 TABLET in 1 BOTTLE (68788-8528-6)Marketed from Oct 6, 2023
68788-8528-8	6878885280868788852808	120 TABLET in 1 BOTTLE (68788-8528-8)Marketed from Oct 6, 2023
68788-8528-9	6878885280968788852809	90 TABLET in 1 BOTTLE (68788-8528-9)Marketed from Oct 6, 2023

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
Generic name (nonproprietary): metformin hydrochloride
Active ingredients: Metformin hydrochloride — 850 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090564
Marketing start: Oct 6, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 68788-8528_88cfb3b0-e0d5-44d5-a989-643432cc676dSPL ID 88cfb3b0-e0d5-44d5-a989-643432cc676dSPL set ID 902d1bc4-3f1f-4a1a-86d7-cf98c56a3684RxCUI 861010UNII 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

N468788852801 followed by a unit qualifier and the quantity

Package 68788-8528-01. 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 Jun 19, 2026. 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. Metformin hydrochloride tablets are biguanide 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. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-8528

What is NDC 68788-8528?: 68788-8528 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 850 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 5 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?: Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 090564

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

FDA NDC Directory listings under ANDA 090564
Product	Strength	Form · route	Labeler	Product NDC
Metformin Hydrochloride	Metformin hydrochloride 850 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3495
Metformin Hydrochloride	Metformin hydrochloride 850 mg/1	TabletOral	Major Pharmaceuticals	0904-7163
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Epic Pharma, LLC	42806-313
Metformin Hydrochloride	Metformin hydrochloride 850 mg/1	Tablet, Film coatedOral	Epic Pharma, LLC	42806-314
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Epic Pharma, LLC	42806-315
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8652
Metformin HCl	Metformin hydrochloride 500 mg/1	TabletOral	Bryant Ranch Prepack	71335-1072
Metformin Hydrochloride	Metformin hydrochloride 850 mg/1	TabletOral	Coupler LLC	67046-0804
Metformin HCl	Metformin hydrochloride 500 mg/1	TabletOral	Ascend Laboratories, LLC	67877-561
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	Major Pharmaceuticals	0904-7162
Metformin HCl	Metformin hydrochloride 850 mg/1	TabletOral	Ascend Laboratories, LLC	67877-562
Metformin HCl	Metformin hydrochloride 1000 mg/1	TabletOral	Ascend Laboratories, LLC	67877-563
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Metcure Pharmaceuticals, Inc.	71709-112
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Metcure Pharmaceuticals, Inc.	71709-110
Metformin Hydrochloride	Metformin hydrochloride 850 mg/1	Tablet, Film coatedOral	Metcure Pharmaceuticals, Inc.	71709-111
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	Major Pharmaceuticals	0904-7164
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	A-S Medication Solutions	50090-7595
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	A-S Medication Solutions	50090-7597
Metformin HCl	Metformin hydrochloride 500 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3541
Metformin HCl	Metformin hydrochloride 500 mg/1	TabletOral	Northwind Health Company, LLC	82868-049

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