NDC codes

FDA NDC Directory
Product NDC (as listed)42708-201Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42708-0201Add 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
42708-201-60427080201604270802016060 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42708-201-60)Marketed from Jun 5, 2026 · Sample package

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 — 500 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
QPharma IncNDC labeler code 42708
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201991
Marketing start
Listing expires
Other FDA classes
Biguanides (Chemical structure)
Identifiers
Product ID 42708-201_5269e7e7-953a-70d8-e063-6394a90a6d04SPL ID 5269e7e7-953a-70d8-e063-6394a90a6d04SPL set ID 5269e91f-7e93-9405-e063-6294a90a3217RxCUI 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

N442708020160 followed by a unit qualifier and the quantity

Package 42708-0201-60. 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 and pediatric patients 10 years of age and older 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 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 42708-201

What is NDC 42708-201?
42708-201 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 500 mg/1 tablet, extended release, listed with the FDA by QPharma Inc. 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?
QPharma Inc, NDC labeler code 42708. 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 201991

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

FDA NDC Directory listings under ANDA 201991
ProductStrengthForm · routeLabelerProduct NDC
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8289
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-1494
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-7116
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-7579
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC51655-559
Metformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralProficient Rx LP63187-779
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralAscend Laboratories, LLC67877-159
Metformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralNuCare Pharmaceuticals, Inc.68071-1419
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralPreferred Pharmaceuticals Inc.68788-8814
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-0886
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-837
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralPD-Rx Pharmaceuticals, Inc.72789-400
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralPD-Rx Pharmaceuticals, Inc.72789-455
Metformin Hydrochloride ERmetformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralLeading Pharma, LLC69315-410

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