Prescription drug · ANDA

Metformin Hydrochloride Extended Release (Metformin hydrochloride) NDC 71610-454

Metformin hydrochloride 500 mg/1 · Tablet, Extended release · Oral · Aphena Pharma Solutions - Tennessee, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)71610-454Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71610-0454Add 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
71610-454-30716100454307161004543030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-454-30)Marketed from Aug 10, 2020
71610-454-53716100454537161004545360 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-454-53)Marketed from Aug 10, 2020
71610-454-60716100454607161004546090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-454-60)Marketed from Aug 7, 2020
71610-454-707161004547071610045470120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-454-70)Marketed from Aug 10, 2020
71610-454-807161004548071610045480180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-454-80)Marketed from Aug 7, 2020
71610-454-927161004549271610045492270 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-454-92)Marketed from Aug 7, 2020
71610-454-947161004549471610045494360 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-454-94)Marketed from Nov 2, 2021

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
Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
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 71610-454_1b06528a-d7ea-4ae9-b5c1-2cc175af1876SPL ID 1b06528a-d7ea-4ae9-b5c1-2cc175af1876SPL set ID 0b843f12-a654-4751-be1f-55e6fce163c9RxCUI 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

N471610045430 followed by a unit qualifier and the quantity

Package 71610-0454-30. 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)

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.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-454

What is NDC 71610-454?
71610-454 is the product NDC for Metformin Hydrochloride Extended Release, Metformin hydrochloride 500 mg/1 tablet, extended release, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 7 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Metformin Hydrochloride Extended Release (Metformin hydrochloride).
What is the active ingredient?
Metformin hydrochloride.
Who is the labeler?
Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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?
10 other product NDCs are listed under this name. See all Metformin Hydrochloride Extended Release NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Metformin Hydrochloride Extended Release NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC51655-55551655-0555-96
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOraldirect rx72189-06472189-0064-3072189-0064-90
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralPD-Rx Pharmaceuticals, Inc.43063-90243063-0902-3043063-0902-60
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralTIME CAP LABORATORIES, INC49483-62349483-0623-0149483-0623-0949483-0623-10+1 more
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralTIME CAP LABORATORIES, INC49483-62449483-0624-0149483-0624-50
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralNuCare Pharmaceuticals, Inc.68071-311168071-3111-0268071-3111-0368071-3111-06+2 more
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-029371335-0293-0171335-0293-0271335-0293-03+6 more
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-088971335-0889-0171335-0889-0271335-0889-03+2 more
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralPD-Rx Pharmaceuticals, Inc.72789-00972789-0009-3072789-0009-6072789-0009-90+1 more
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralProficient Rx LP82804-14882804-0148-0082804-0148-30

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 HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralMARKSANS PHARMA LIMITED25000-101
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralMARKSANS PHARMA LIMITED25000-102
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralPD-Rx Pharmaceuticals, Inc.43063-902
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralTIME CAP LABORATORIES, INC49483-623
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralTIME CAP LABORATORIES, INC49483-624
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC51655-555
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralNuCare Pharmaceuticals, Inc.68071-3111
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-0293
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-0889
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOraldirect rx72189-064
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralPD-Rx Pharmaceuticals, Inc.72789-009
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralProficient Rx LP82804-148

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