What is NDC 83301-0010?

83301-0010 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 1000 mg/1 tablet, coated, listed with the FDA by Mullan Pharmaceutical Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Mullan Pharmaceutical Inc., NDC labeler code 83301. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Metformin Hydrochloride NDC 83301-0010

NDC codes

FDA NDC Directory

Product NDC (as listed)83301-0010Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83301-0010Add 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 NDC	11-digit (billing)	Package
83301-0010-1	8330100100183301001001	100 TABLET, COATED in 1 BOTTLE (83301-0010-1)Marketed from Jan 1, 2024
83301-0010-2	8330100100283301001002	500 TABLET, COATED in 1 BOTTLE (83301-0010-2)Marketed from Jan 1, 2024
83301-0010-3	8330100100383301001003	1000 TABLET, COATED in 1 BOTTLE (83301-0010-3)Marketed from Jan 1, 2024

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, Coated
Route: Oral
Labeler: Mullan Pharmaceutical Inc.NDC labeler code 83301
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205096
Marketing start: Jan 1, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 83301-0010_423f5f82-8524-65aa-e063-6294a90a1180SPL ID 423f5f82-8524-65aa-e063-6294a90a1180SPL set ID 082b4de9-e452-fe71-e063-6394a90ac863RxCUI 861004, 861007, 861010UNII 786Z46389EUPC 0383301001014, 0383301000826, 0383301000925
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

N483301001001 followed by a unit qualifier and the quantity

Package 83301-0010-01. 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 Oct 28, 2025. 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 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 83301-0010

What is NDC 83301-0010?: 83301-0010 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 1000 mg/1 tablet, coated, listed with the FDA by Mullan Pharmaceutical Inc.. It has 3 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?: Mullan Pharmaceutical Inc., NDC labeler code 83301. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4781	70518-4781-00
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Marlex Pharmaceuticals, Inc.	10135-823	10135-0823-0510135-0823-1010135-0823-30+5 more
Metformin Hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	Marlex Pharmaceuticals, Inc.	10135-824	10135-0824-0510135-0824-1010135-0824-90
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4185	68788-4185-0168788-4185-0368788-4185-06+3 more
Metformin Hydrochloride	Metformin hydrochloride 625 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-588	50228-0588-0550228-0588-30
Metformin Hydrochloride	Metformin hydrochloride 750 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-589	50228-0589-0550228-0589-30
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4710	70518-4710-0070518-4710-02
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	REMEDYREPACK INC.	70518-4698	70518-4698-00
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0591	80425-0591-0180425-0591-0280425-0591-03+1 more
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-054	87441-0054-01

All 367 Metformin Hydrochloride NDCs

Other NDCs under ANDA 205096

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

FDA NDC Directory listings under ANDA 205096
Product	Strength	Form · route	Labeler	Product NDC
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, CoatedOral	A-S Medication Solutions	50090-7578
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, CoatedOral	NuCare Pharmaceuticals, Inc.	68071-3976
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, CoatedOral	A-S Medication Solutions	50090-7278
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, CoatedOral	A-S Medication Solutions	50090-7280
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, CoatedOral	Mullan Pharmaceutical Inc.	83301-0008
Metformin Hydrochloride	Metformin hydrochloride 850 mg/1	Tablet, CoatedOral	Mullan Pharmaceutical Inc.	83301-0009
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, CoatedOral	Precision Dose, Inc.	68094-480
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, CoatedOral	Westminster Pharmaceuticals, LLC	69367-381
Metformin Hydrochloride	Metformin hydrochloride 850 mg/1	Tablet, CoatedOral	Precision Dose, Inc.	68094-580
Metformin Hydrochloride	Metformin hydrochloride 850 mg/1	Tablet, CoatedOral	Westminster Pharmaceuticals, LLC	69367-382
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, CoatedOral	Westminster Pharmaceuticals, LLC	69367-383
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, CoatedOral	Precision Dose, Inc.	68094-688
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, CoatedOral	A-S Medication Solutions	50090-7454
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, CoatedOral	A-S Medication Solutions	50090-7455
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, CoatedOral	Coupler, LLC	67046-1554