NDC codes

FDA NDC Directory
Product NDC (as listed)71610-578Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71610-0578Add 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
71610-578-607161005786090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-60)Marketed from Jul 1, 2021
71610-578-7071610057870120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-70)Marketed from Jul 1, 2021
71610-578-8071610057880180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-80)Marketed from Jul 1, 2021
71610-578-9471610057894360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-94)Marketed from Jul 1, 2021

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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206145
Marketing start
Listing expires
Other FDA classes
Biguanides (Chemical structure)
Identifiers
Product ID 71610-578_ae39b6bc-4b1a-4db9-b5a1-7195832a1cecSPL ID ae39b6bc-4b1a-4db9-b5a1-7195832a1cecSPL set ID 1e298db3-439e-4e91-8f9e-01c3cdc4d552RxCUI 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

N471610057860 followed by a unit qualifier and the quantity

Package 71610-0578-60. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 206145

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

FDA NDC Directory listings under ANDA 206145
ProductStrengthForm · routeLabelerProduct NDC
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-5396
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-5397
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralAscend Laboratories, LLC67877-413
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralAscend Laboratories, LLC67877-414
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralProficient Rx LP71205-686
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-6839
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralQuallent Pharmaceuticals Health LLC82009-180
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralQuallent Pharmaceuticals Health LLC82009-181
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC51655-077
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralPD-Rx Pharmaceuticals, Inc.72789-472
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC51655-853
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-5246

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