Prescription drug · ANDA

Metformin Hydrochloride NDC 25000-102

Metformin hydrochloride 750 mg/1 · Tablet, Extended release · Oral · MARKSANS PHARMA LIMITED

NDC codes

FDA NDC Directory
Product NDC (as listed)25000-102Labeler and product segments. Claims need a package NDC.
Product NDC at billing width25000-0102Add 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
25000-102-032500001020330 TABLET, EXTENDED RELEASE in 1 BOTTLE (25000-102-03)Marketed from May 12, 2016
25000-102-1225000010212500 TABLET, EXTENDED RELEASE in 1 BOTTLE (25000-102-12)Marketed from May 12, 2016
25000-102-53250000102534 BAG in 1 BOX (25000-102-53) / 1500 TABLET, EXTENDED RELEASE in 1 BAGMarketed from May 12, 2016
25000-102-98250000102981 BAG in 1 BOX (25000-102-98) / 8510 TABLET, EXTENDED RELEASE in 1 BAGMarketed from May 12, 2016

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 — 750 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090295
Marketing start
Listing expires
Other FDA classes
Biguanides (Chemical structure)
Identifiers
Product ID 25000-102_2e4551d7-a4e0-4b7a-b7d6-b05021007658SPL ID 2e4551d7-a4e0-4b7a-b7d6-b05021007658SPL set ID d09a2eda-fdd8-44ed-8e2f-ea91ddfd3c68RxCUI 860975, 860981UNII 786Z46389EUPC 0325000101039, 0325000102036, 0325000101145, 0325000101121, 0325000102128
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

N425000010203 followed by a unit qualifier and the quantity

Package 25000-0102-03. 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, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin Hydrochloride Extended-Release Tablet is a biguanide 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 090295

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

FDA NDC Directory listings under ANDA 090295
ProductStrengthForm · routeLabelerProduct NDC
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralNuCare Pharmaceuticals, Inc.68071-3111
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralProficient Rx LP82804-148
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC51655-555
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralPD-Rx Pharmaceuticals, Inc.43063-902
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralMARKSANS PHARMA LIMITED25000-101
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralPD-Rx Pharmaceuticals, Inc.72789-009
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralTIME CAP LABORATORIES, INC49483-623
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-454
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralTIME CAP LABORATORIES, INC49483-624
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-0889
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-0293
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOraldirect rx72189-064

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Metformin Hydrochloride NDC 25000-102 | Med-Code