NDC codes

FDA NDC Directory
Product NDC (as listed)42385-949Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42385-0949Add 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
42385-949-014238509490142385094901100 TABLET, FILM COATED in 1 BOTTLE (42385-949-01)Marketed from Jul 20, 2021
42385-949-054238509490542385094905500 TABLET, FILM COATED in 1 BOTTLE (42385-949-05)Marketed from Jul 20, 2021
42385-949-1142385094911423850949111000 TABLET, FILM COATED in 1 BOTTLE (42385-949-11)Marketed from May 17, 2021
42385-949-184238509491842385094918180 TABLET, FILM COATED in 1 BOTTLE (42385-949-18)Marketed from Jul 20, 2021
42385-949-19423850949194238509491910 BLISTER PACK in 1 CARTON (42385-949-19) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 17, 2021
42385-949-60423850949604238509496060 TABLET, FILM COATED in 1 BOTTLE (42385-949-60)Marketed from May 17, 2021
42385-949-90423850949904238509499090 TABLET, FILM COATED in 1 BOTTLE (42385-949-90)Marketed from Aug 1, 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 — 1000 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Laurus Labs LimitedNDC labeler code 42385
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209882
Marketing start
Listing expires
Other FDA classes
Biguanides (Chemical structure)
Identifiers
Product ID 42385-949_59e47cee-79d7-4adc-9a71-165c170e5006SPL ID 59e47cee-79d7-4adc-9a71-165c170e5006
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

N442385094901 followed by a unit qualifier and the quantity

Package 42385-0949-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 42385-949

What is NDC 42385-949?
42385-949 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 1000 mg/1 tablet, film coated, listed with the FDA by Laurus Labs Limited. It has 7 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?
Laurus Labs Limited, NDC labeler code 42385. 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 209882

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

FDA NDC Directory listings under ANDA 209882
ProductStrengthForm · routeLabelerProduct NDC
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralCoupler LLC67046-1594
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2224
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7866
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8756
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2533
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-3833
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8498
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralLaurus Labs Limited42385-947
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralLaurus Labs Limited42385-948
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7107
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7106
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2593
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4262
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6859
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6856
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6857
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6858
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8600
Metformin HCLMetformin hydrochloride 500 mg/1Tablet, Film coatedOralDirect_Rx72189-658
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-644

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