What is NDC 68645-584?

68645-584 is the product NDC for Metformin hydrochloride, Metformin hydrochloride 1000 mg/1 tablet, listed with the FDA by Legacy Pharmaceutical Packaging, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Legacy Pharmaceutical Packaging, LLC, NDC labeler code 68645. 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?

358 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 68645-584 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68645-584Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68645-0584Add 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
68645-584-59	68645058459	60 TABLET in 1 BOTTLE (68645-584-59)Marketed from Jun 7, 2019

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 — 1000 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Legacy Pharmaceutical Packaging, LLCNDC labeler code 68645
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090564
Marketing start: Jun 7, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 68645-584_4cc25d36-a09a-4f23-e063-6294a90a665dSPL ID 4cc25d36-a09a-4f23-e063-6294a90a665dSPL set ID b51da8d7-ab4a-4c40-97c9-88bd379366d1RxCUI 861004, 861007, 861010UNII 786Z46389EUPC 0368645582597, 0368645583594, 0368645584591
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

N468645058459 followed by a unit qualifier and the quantity

Package 68645-0584-59. 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 Mar 11, 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 68645-584

What is NDC 68645-584?: 68645-584 is the product NDC for Metformin hydrochloride, Metformin hydrochloride 1000 mg/1 tablet, listed with the FDA by Legacy Pharmaceutical Packaging, LLC. It has 1 package NDC, 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?: Legacy Pharmaceutical Packaging, LLC, NDC labeler code 68645. 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?: 358 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 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
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4677	70518-4677-0070518-4677-01

All 359 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 HCl	Metformin hydrochloride 500 mg/1	TabletOral	QPharma, Inc.	42708-009
Metformin HCl	Metformin hydrochloride 1000 mg/1	TabletOral	QPharma, Inc.	42708-018
Metformin HCl	Metformin hydrochloride 850 mg/1	TabletOral	A-S Medication Solutions	50090-3050
Metformin HCl	Metformin hydrochloride 500 mg/1	TabletOral	A-S Medication Solutions	50090-3064
Metformin HCl	Metformin hydrochloride 1000 mg/1	TabletOral	A-S Medication Solutions	50090-3579
Metformin HCl	Metformin hydrochloride 500 mg/1	TabletOral	A-S Medication Solutions	50090-4891
Metformin HCl	Metformin hydrochloride 1000 mg/1	TabletOral	A-S Medication Solutions	50090-4892
Metformin HCl	Metformin hydrochloride 850 mg/1	TabletOral	A-S Medication Solutions	50090-7465
Metformin HCl	Metformin hydrochloride 1000 mg/1	TabletOral	A-S Medication Solutions	50090-7750
Metformin HCl	Metformin hydrochloride 500 mg/1	TabletOral	Ascend Laboratories, LLC	67877-561
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 HCl	Metformin hydrochloride 500 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3541
Metformin HCl	Metformin hydrochloride 1000 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3697
Metformin HCl	Metformin hydrochloride 850 mg/1	TabletOral	REMEDYREPACK INC.	70518-4479
Metformin HCl	Metformin hydrochloride 1000 mg/1	TabletOral	Proficient Rx LP	71205-548
Metformin HCl	Metformin hydrochloride 500 mg/1	TabletOral	Proficient Rx LP	71205-562
Metformin HCl	Metformin hydrochloride 850 mg/1	TabletOral	Proficient Rx LP	71205-567
Metformin HCl	Metformin hydrochloride 500 mg/1	TabletOral	Bryant Ranch Prepack	71335-1072
Metformin HCl	Metformin hydrochloride 850 mg/1	TabletOral	Bryant Ranch Prepack	71335-1983

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