Prescription drug · ANDA

Metformin Hydrochloride NDC 0615-8629

Metformin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · NCS HealthCare of KY, LLC dba Vangard Labs

NDC codes

FDA NDC Directory
Product NDC (as listed)0615-8629Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00615-8629Add 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
0615-8629-050061586290515 TABLET, FILM COATED in 1 BLISTER PACK (0615-8629-05)Marketed from Mar 31, 2026
0615-8629-280061586292828 TABLET, FILM COATED in 1 BLISTER PACK (0615-8629-28)Marketed from Mar 31, 2026
0615-8629-30006158629306 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8629-30) / 5 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 14, 2026
0615-8629-390061586293930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8629-39)Marketed from Mar 31, 2026

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077095
Marketing start
Listing expires
Other FDA classes
Biguanides (Chemical structure)
Identifiers
Product ID 0615-8629_eda81df8-05d9-4eac-b058-7eb51d7aa6e4SPL ID eda81df8-05d9-4eac-b058-7eb51d7aa6e4SPL set ID 0448c618-2f0d-4ed3-866f-74b413cf902dRxCUI 861004, 861007, 861010UNII 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

N400615862905 followed by a unit qualifier and the quantity

Package 00615-8629-05. 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 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 is 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)

Other NDCs under ANDA 077095

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

FDA NDC Directory listings under ANDA 077095
ProductStrengthForm · routeLabelerProduct NDC
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-4185
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7868
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralProficient Rx LP63187-239
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralProficient Rx LP63187-238
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3130
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-3132
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-854
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-855
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-856
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2081
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8577
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-1149
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-649
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6485
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8578
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-009
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-008
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-010
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8015
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-5313

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Metformin Hydrochloride NDC 0615-8629 | Med-Code