NDC codes

FDA NDC Directory
Product NDC (as listed)70518-4639Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-4639Add 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
70518-4639-07051846390050 POUCH in 1 BOX (70518-4639-0) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4639-1)Marketed from Apr 27, 2026

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 — 500 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078321
Marketing start
Listing expires
Other FDA classes
Biguanides (Chemical structure)
Identifiers
Product ID 70518-4639_5bc6d490-46a5-4f0e-e063-6294a90a38ebSPL ID 5bc6d490-46a5-4f0e-e063-6294a90a38eb
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

N470518463900 followed by a unit qualifier and the quantity

Package 70518-4639-00. 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.

Other NDCs under ANDA 078321

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

FDA NDC Directory listings under ANDA 078321
ProductStrengthForm · routeLabelerProduct NDC
Metformin Hydrochloride Extended-Release 500mgmetformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralCalvin Scott & Co., Inc.17224-311
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-533
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralPD-Rx Pharmaceuticals, Inc.72789-548
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralAvPAK50268-550
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralAvPAK50268-551
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralPreferred Pharmaceuticals Inc.68788-7205
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOraldirect rx72189-150
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-3166
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralProficient Rx LP82804-195
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralProficient Rx LP71205-141
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralTAGI Pharma, Inc.51224-007
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralTAGI Pharma, Inc.51224-107
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralPreferred Pharmaceuticals Inc.68788-8903
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralProficient Rx LP71205-186
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-2504
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-0720
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralPD-Rx Pharmaceuticals, Inc.72789-454
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralPD-Rx Pharmaceuticals, Inc.72789-451
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-0776
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-2709

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