NDC codes

FDA NDC Directory
Product NDC (as listed)68788-4185Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-4185Add 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 NDC11-digit (billing)PackageCopy
68788-4185-16878841850168788418501100 TABLET, FILM COATED in 1 BOTTLE (68788-4185-1)Marketed from Aug 27, 2026
68788-4185-3687884185036878841850330 TABLET, FILM COATED in 1 BOTTLE (68788-4185-3)Marketed from Aug 27, 2026
68788-4185-6687884185066878841850660 TABLET, FILM COATED in 1 BOTTLE (68788-4185-6)Marketed from Aug 27, 2026
68788-4185-76878841850768788418507180 TABLET, FILM COATED in 1 BOTTLE (68788-4185-7)Marketed from Aug 27, 2026
68788-4185-86878841850868788418508120 TABLET, FILM COATED in 1 BOTTLE (68788-4185-8)Marketed from Aug 27, 2026
68788-4185-9687884185096878841850990 TABLET, FILM COATED in 1 BOTTLE (68788-4185-9)Marketed from Aug 27, 2026

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, Film coated
Route
Oral
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077095
Marketing start
Listing expires
Other FDA classes
Biguanides (Chemical structure)
Identifiers
Product ID 68788-4185_ba0379cb-824e-4798-9ff9-99bcd1bea5cbSPL ID ba0379cb-824e-4798-9ff9-99bcd1bea5cbSPL set ID ba0379cb-824e-4798-9ff9-99bcd1bea5cbRxCUI 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

N468788418501 followed by a unit qualifier and the quantity

Package 68788-4185-01. 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 . 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 is 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 68788-4185

What is NDC 68788-4185?
68788-4185 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 1000 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 6 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-478170518-4781-00
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralMarlex Pharmaceuticals, Inc.10135-82310135-0823-0510135-0823-1010135-0823-30+5 more
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralMarlex Pharmaceuticals, Inc.10135-82410135-0824-0510135-0824-1010135-0824-90
Metformin HydrochlorideMetformin hydrochloride 625 mg/1TabletOralScieGen Pharmaceuticals Inc50228-58850228-0588-0550228-0588-30
Metformin HydrochlorideMetformin hydrochloride 750 mg/1TabletOralScieGen Pharmaceuticals Inc50228-58950228-0589-0550228-0589-30
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-471070518-4710-0070518-4710-02
Metformin HydrochlorideMetformin hydrochloride 500 mg/1TabletOralREMEDYREPACK INC.70518-469870518-4698-00
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-059180425-0591-0180425-0591-0280425-0591-03+1 more
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1TabletOralUnit Dose Solutions, Inc.87441-05487441-0054-01
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-467770518-4677-0070518-4677-0170518-4677-03

All 367 Metformin Hydrochloride NDCs

Other NDCs under ANDA 077095

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

FDA NDC Directory listings under ANDA 077095
ProductStrengthForm · routeLabelerProduct NDC
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8015
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8577
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8578
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8629
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2081
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5052
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6485
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7868
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-8106
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-649
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-854
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-855
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-856
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralProficient Rx LP63187-238
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralProficient Rx LP63187-239
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-5313
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-5323
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-1149
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3130
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-3132

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