Prescription drug · ANDA

Metformin Hydrochloride Extended Release (Metformin hydrochloride) NDC 71335-0293

Metformin hydrochloride 500 mg/1 · Tablet, Extended release · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)71335-0293Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-0293Add 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
71335-0293-1713350293017133502930160 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0293-1)Marketed from Mar 19, 2018
71335-0293-2713350293027133502930230 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0293-2)Marketed from Oct 30, 2018
71335-0293-37133502930371335029303100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0293-3)Marketed from Aug 19, 2019
71335-0293-4713350293047133502930490 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0293-4)Marketed from Mar 2, 2018
71335-0293-57133502930571335029305120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0293-5)Marketed from Mar 23, 2018
71335-0293-6713350293067133502930615 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0293-6)Marketed from Feb 14, 2018
71335-0293-7713350293077133502930745 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0293-7)Marketed from Feb 23, 2022
71335-0293-87133502930871335029308180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0293-8)Marketed from Feb 16, 2018
71335-0293-9713350293097133502930920 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0293-9)Marketed from Feb 23, 2022

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

Generic name (nonproprietary)
metformin hydrochloride
Active ingredients
Metformin hydrochloride — 500 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
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 71335-0293_1210ee1b-4a39-4f60-af08-02eeca33dfcaSPL ID 1210ee1b-4a39-4f60-af08-02eeca33dfcaSPL set ID 3e55944a-ed5b-4892-804f-abbe15b0d70cRxCUI 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

N471335029301 followed by a unit qualifier and the quantity

Package 71335-0293-01. 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 71335-0293

What is NDC 71335-0293?
71335-0293 is the product NDC for Metformin Hydrochloride Extended Release, Metformin hydrochloride 500 mg/1 tablet, extended release, listed with the FDA by Bryant Ranch Prepack. It has 9 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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 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 releaseOralAphena Pharma Solutions - Tennessee, LLC71610-45471610-0454-3071610-0454-5371610-0454-60+4 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 750 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-0889
Metformin Hydrochloride Extended Releasemetformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-454
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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