What is NDC 68788-8560?

68788-8560 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 1000 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 68788-8560

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-8560Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-8560Add 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
68788-8560-1	6878885600168788856001	100 TABLET in 1 BOTTLE (68788-8560-1)Marketed from Jan 8, 2024
68788-8560-3	6878885600368788856003	30 TABLET in 1 BOTTLE (68788-8560-3)Marketed from Jan 8, 2024
68788-8560-6	6878885600668788856006	60 TABLET in 1 BOTTLE (68788-8560-6)Marketed from Jan 8, 2024
68788-8560-8	6878885600868788856008	120 TABLET in 1 BOTTLE (68788-8560-8)Marketed from Jan 8, 2024
68788-8560-9	6878885600968788856009	90 TABLET in 1 BOTTLE (68788-8560-9)Marketed from Jan 8, 2024

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 — 1000 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 213320
Marketing start: Jan 8, 2024
Marketing end: Dec 30, 2026
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 68788-8560_f1743b2e-36f8-43e7-b409-62ed64e411a2SPL ID f1743b2e-36f8-43e7-b409-62ed64e411a2SPL set ID 4182bcf0-1f9a-4f3a-9428-86b5d757954fRxCUI 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

N468788856001 followed by a unit qualifier and the quantity

Package 68788-8560-01. 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 22, 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 a 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 68788-8560

What is NDC 68788-8560?: 68788-8560 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 1000 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 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 HCL	Metformin hydrochloride 1000 mg/1	TabletOral	Direct_Rx	72189-635
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

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