NDC codes

FDA NDC Directory
Product NDC (as listed)17224-311Labeler and product segments. Claims need a package NDC.
Product NDC at billing width17224-0311Add 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
17224-311-28172240311281722403112828 TABLET, EXTENDED RELEASE in 1 BOTTLE (17224-311-28)Marketed from Jun 8, 2017

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

Generic name (nonproprietary)
metformin hydrochloride
Active ingredients
Metformin hydrochloride — 500 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
Calvin Scott & Co., Inc.NDC labeler code 17224
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 17224-311_da8083b6-aeff-e1ee-e053-2a95a90a0844SPL ID da8083b6-aeff-e1ee-e053-2a95a90a0844SPL set ID e9cd0d23-56eb-40dd-abf4-9e681ec220f5RxCUI 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

N417224031128 followed by a unit qualifier and the quantity

Package 17224-0311-28. 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 .

Indications (excerpt from the label)

USES: Metformin is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. It is used in patients with type 2 diabetes (non-insulin-dependent diabetes). Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Metformin works by helping to restore your body's proper response to the insulin you naturally produce. It also decreases the amount of sugar that your liver makes and that your stomach/intestines absorb.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 17224-311

What is NDC 17224-311?
17224-311 is the product NDC for Metformin Hydrochloride Extended-Release 500mg, Metformin hydrochloride 500 mg/1 tablet, extended release, listed with the FDA by Calvin Scott & Co., Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Metformin Hydrochloride Extended-Release 500mg (Metformin hydrochloride).
What is the active ingredient?
Metformin hydrochloride.
Who is the labeler?
Calvin Scott & Co., Inc., NDC labeler code 17224. 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 Extended-Release 500mg?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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 HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralAvPAK50268-550
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralAvPAK50268-551
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 750 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC51655-368
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralRedPharm Drug, Inc.67296-1701
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralPrecision Dose, Inc.68094-804
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralPrecision Dose, Inc.68094-904
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralPreferred Pharmaceuticals Inc.68788-8903
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-2709
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-4163
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-4639
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralProficient Rx LP71205-141
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralProficient Rx LP71205-186
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-0720
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-0776
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-2504
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-3166
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-533
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOraldirect rx72189-150

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