NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8903Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8903Add 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
68788-8903-16878889030168788890301100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-1)Marketed from Jul 31, 2025
68788-8903-3687888903036878889030330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-3)Marketed from Jul 31, 2025
68788-8903-6687888903066878889030660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-6)Marketed from Jul 31, 2025
68788-8903-86878889030868788890308120 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-8)Marketed from Jul 31, 2025
68788-8903-9687888903096878889030990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-9)Marketed from Jul 31, 2025

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 — 500 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078321
Marketing start
Listing expires
Other FDA classes
Biguanides (Chemical structure)
Identifiers
Product ID 68788-8903_e55ee270-5eb9-4848-8529-9af2a79669c0SPL ID e55ee270-5eb9-4848-8529-9af2a79669c0SPL set ID e55ee270-5eb9-4848-8529-9af2a79669c0RxCUI 860975UNII 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

N468788890301 followed by a unit qualifier and the quantity

Package 68788-8903-01. 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 extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults 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 68788-8903

What is NDC 68788-8903?
68788-8903 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 500 mg/1 tablet, extended release, 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
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 1000 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-418568788-4185-0168788-4185-0368788-4185-06+3 more
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

All 367 Metformin Hydrochloride NDCs

Other NDCs under ANDA 078321

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

FDA NDC Directory listings under ANDA 078321
ProductStrengthForm · routeLabelerProduct NDC
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralAvPAK50268-550
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralAvPAK50268-551
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralTAGI Pharma, Inc.51224-007
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralTAGI Pharma, Inc.51224-107
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC51655-368
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralRedPharm Drug, Inc.67296-1701
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralPrecision Dose, Inc.68094-804
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralPrecision Dose, Inc.68094-904
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-2709
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-4163
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-4639
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralProficient Rx LP71205-141
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralProficient Rx LP71205-186
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-0720
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-0776
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-2504
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-3166
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-533
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOraldirect rx72189-150
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralPD-Rx Pharmaceuticals, Inc.72789-451

Showing 20 of 24.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in