NDC codes

FDA NDC Directory
Product NDC (as listed)62135-683Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62135-0683Add 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
62135-683-056213506830562135068305500 TABLET in 1 BOTTLE (62135-683-05)Marketed from Apr 6, 2022
62135-683-1062135068310621350683101000 TABLET in 1 BOTTLE (62135-683-10)Marketed from Apr 6, 2022
62135-683-186213506831862135068318180 TABLET in 1 BOTTLE (62135-683-18)Marketed from Apr 6, 2022
62135-683-30621350683306213506833030 TABLET in 1 BOTTLE (62135-683-30)Marketed from Apr 6, 2022
62135-683-90621350683906213506839090 TABLET in 1 BOTTLE (62135-683-90)Marketed from Apr 6, 2022

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 — 850 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Chartwell RX, LLCNDC labeler code 62135
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075972
Marketing start
Listing expires
Other FDA classes
Biguanides (Chemical structure)
Identifiers
Product ID 62135-683_570c5a61-a145-01f8-e063-6394a90acba5SPL ID 570c5a61-a145-01f8-e063-6394a90acba5SPL set ID 4d3dbf6f-1c8a-4daa-8343-8cd8f64a65cdRxCUI 861004, 861007, 861010, 861021, 2703582UNII 786Z46389EUPC 0362135684051, 0362135681302, 0362135682309, 0362135680053, 0362135684907, 0362135683184, 0362135680183, 0362135680909, 0362135683306, 0362135684181, 0362135683900
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

N462135068305 followed by a unit qualifier and the quantity

Package 62135-0683-05. 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 is 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 62135-683

What is NDC 62135-683?
62135-683 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 850 mg/1 tablet, listed with the FDA by Chartwell RX, LLC. 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?
Chartwell RX, LLC, NDC labeler code 62135. 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 075972

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

FDA NDC Directory listings under ANDA 075972
ProductStrengthForm · routeLabelerProduct NDC
Metformin HydrochlorideMetformin hydrochloride 500 mg/1TabletOralChartwell RX, LLC62135-680
Metformin HydrochlorideMetformin hydrochloride 625 mg/1TabletOralChartwell RX, LLC62135-681
Metformin HydrochlorideMetformin hydrochloride 750 mg/1TabletOralChartwell RX, LLC62135-682
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1TabletOralChartwell RX, LLC62135-684
Metformin HydrochlorideMetformin hydrochloride 625 mg/1TabletOralLifsa Drugs, LLC72336-064
Metformin HydrochlorideMetformin hydrochloride 750 mg/1TabletOralLifsa Drugs, LLC72336-095

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