What is NDC 71093-133?

71093-133 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 850 mg/1 tablet, listed with the FDA by ACI Healthcare USA, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

ACI Healthcare USA, Inc., NDC labeler code 71093. 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?

366 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Metformin Hydrochloride NDC 71093-133

NDC codes

FDA NDC Directory

Product NDC (as listed)71093-133Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71093-0133Add 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 NDC	11-digit (billing)	Package	Copy
71093-133-04	7109301330471093013304	100 TABLET in 1 BOTTLE, PLASTIC (71093-133-04)Marketed from Jan 15, 2018
71093-133-05	7109301330571093013305	500 TABLET in 1 BOTTLE, PLASTIC (71093-133-05)Marketed from Jan 15, 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 Hydrochloride
Generic name (nonproprietary): metformin hydrochloride
Active ingredients: Metformin hydrochloride — 850 mg/1
Dosage form: Tablet
Route: Oral
Labeler: ACI Healthcare USA, Inc.NDC labeler code 71093
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203769
Marketing start: Jan 15, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 71093-133_39bb2259-ba80-4602-b468-a2e0d61f48f6SPL ID 39bb2259-ba80-4602-b468-a2e0d61f48f6SPL set ID e18b60f9-721e-4db6-9f61-d3437e18faf2RxCUI 861004, 861007, 861010UNII 786Z46389EUPC 0371093133044, 0371093134041, 0371093132047
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

N471093013304 followed by a unit qualifier and the quantity

Package 71093-0133-04. 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 Dec 26, 2020. This label includes a boxed warning.

Indications (excerpt from the label)

Metformin Hydrochloride Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71093-133

What is NDC 71093-133?: 71093-133 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 850 mg/1 tablet, listed with the FDA by ACI Healthcare USA, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Metformin Hydrochloride.
What is the active ingredient?: Metformin hydrochloride.
Who is the labeler?: ACI Healthcare USA, Inc., NDC labeler code 71093. 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?: 366 other product NDCs are listed under this name. See all Metformin Hydrochloride 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 NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4781	70518-4781-00
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Marlex Pharmaceuticals, Inc.	10135-823	10135-0823-0510135-0823-1010135-0823-30+5 more
Metformin Hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	Marlex Pharmaceuticals, Inc.	10135-824	10135-0824-0510135-0824-1010135-0824-90
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4185	68788-4185-0168788-4185-0368788-4185-06+3 more
Metformin Hydrochloride	Metformin hydrochloride 625 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-588	50228-0588-0550228-0588-30
Metformin Hydrochloride	Metformin hydrochloride 750 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-589	50228-0589-0550228-0589-30
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4710	70518-4710-0070518-4710-02
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	REMEDYREPACK INC.	70518-4698	70518-4698-00
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0591	80425-0591-0180425-0591-0280425-0591-03+1 more
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-054	87441-0054-01

All 367 Metformin Hydrochloride NDCs

Other NDCs under ANDA 203769

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

FDA NDC Directory listings under ANDA 203769
Product	Strength	Form · route	Labeler	Product NDC
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	Preferred Pharmaceuticals Inc	68788-4076
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Westminster Pharmaceuticals, LLC	69367-180
Metformin Hydrochloride	Metformin hydrochloride 850 mg/1	Tablet, Film coatedOral	Westminster Pharmaceuticals, LLC	69367-181
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Westminster Pharmaceuticals, LLC	69367-182
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	A-S Medication Solutions	50090-7588
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	A-S Medication Solutions	50090-7586
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	A-S Medication Solutions	50090-7587
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	Bryant Ranch Prepack	72162-1522
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	direct rx	72189-219
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	Bryant Ranch Prepack	72162-1523
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	direct rx	72189-220
Metformin Hydrochloride	Metformin hydrochloride 850 mg/1	TabletOral	direct rx	72189-221
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-672
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-917
Metformin Hydrochloride	Metformin hydrochloride 850 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-918
Metformin Hydrochloride	Metformin hydrochloride 850 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-923
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-783
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-784
Metformin Hydrochloride	Metformin hydrochloride 625 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-588
Metformin Hydrochloride	Metformin hydrochloride 750 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-589

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