NDC codes

FDA NDC Directory
Product NDC (as listed)50742-633Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50742-0633Add 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
50742-633-10507420633101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-633-10)Marketed from Dec 10, 2018
50742-633-605074206336060 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-633-60)Marketed from Dec 10, 2018
50742-633-905074206339090 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-633-90)Marketed from Dec 10, 2018

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
Generic name (nonproprietary)
metformin
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 209674
Marketing start
Listing expires
Other FDA classes
Biguanides (Chemical structure)
Identifiers
Product ID 50742-633_3a97a225-ff03-4d81-a2fe-7f66611cc4c1SPL ID 3a97a225-ff03-4d81-a2fe-7f66611cc4c1SPL set ID 49a0b5c2-ebaf-4c4c-905f-dfd1962ac647RxCUI 1807894, 1807917UNII 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

N450742063310 followed by a unit qualifier and the quantity

Package 50742-0633-10. 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 extended-release tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209674

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

FDA NDC Directory listings under ANDA 209674
ProductStrengthForm · routeLabelerProduct NDC
MetforminMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralCoupler LLC67046-1557
MetforminMetformin hydrochloride 1000 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-634
MetforminMetformin hydrochloride 1000 mg/1Tablet, Extended releaseOralCoupler LLC67046-1584
MetforminMetformin hydrochloride 1000 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-4651

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