Prescription drug · ANDA

Metformin Hydrochloride NDC 50090-1494

Metformin hydrochloride 500 mg/1 · Tablet, Extended release · Oral · A-S Medication Solutions

NDC codes

FDA NDC Directory
Product NDC (as listed)50090-1494Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-1494Add 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
50090-1494-05009014940060 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-1494-0)Marketed from Dec 4, 2014
50090-1494-15009014940130 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-1494-1)Marketed from Dec 4, 2014
50090-1494-25009014940290 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-1494-2)Marketed from Dec 4, 2014
50090-1494-350090149403180 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-1494-3)Marketed from Dec 4, 2014
50090-1494-450090149404100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-1494-4)Marketed from Mar 12, 2024

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 201991
Marketing start
Listing expires
Other FDA classes
Biguanides (Chemical structure)
Identifiers
Product ID 50090-1494_c83706bb-e844-4e62-b4f4-c48536ea707dSPL ID c83706bb-e844-4e62-b4f4-c48536ea707dSPL set ID 0cd086d6-3ae2-476e-b93e-29055e67e8fcRxCUI 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

N450090149400 followed by a unit qualifier and the quantity

Package 50090-1494-00. 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

Current FDA label (SPL), effective . This label includes a boxed warning.

Indications (excerpt from the label)

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. 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 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 201991

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

FDA NDC Directory listings under ANDA 201991
ProductStrengthForm · routeLabelerProduct NDC
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralQPharma Inc42708-201
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC51655-559
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-837
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-7116
Metformin Hydrochloride ERmetformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralLeading Pharma, LLC69315-410
Metformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralProficient Rx LP63187-779
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralPD-Rx Pharmaceuticals, Inc.72789-400
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8289
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralPreferred Pharmaceuticals Inc.68788-8814
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralAscend Laboratories, LLC67877-159
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralPD-Rx Pharmaceuticals, Inc.72789-455
Metformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralNuCare Pharmaceuticals, Inc.68071-1419
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-7579
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-0886

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