What is NDC 75834-255?

75834-255 is the product NDC for Atorvastatin calcium, Atorvastatin 10 mg/1 tablet, listed with the FDA by NIVAGEN PHARMACEUTICALS, INC.. It has 4 package NDCs, shown above in 10- and 11-digit form.

NIVAGEN PHARMACEUTICALS, INC., NDC labeler code 75834. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Atorvastatin calcium?

389 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Atorvastatin calcium NDC 75834-255

NDC codes

FDA NDC Directory

Product NDC (as listed)75834-255Labeler and product segments. Claims need a package NDC.

Product NDC at billing width75834-0255Add 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
75834-255-01	7583402550175834025501	1000 TABLET in 1 BOTTLE (75834-255-01)Marketed from Aug 26, 2020
75834-255-05	7583402550575834025505	5000 TABLET in 1 BOTTLE (75834-255-05)Marketed from Aug 26, 2020
75834-255-50	7583402555075834025550	500 TABLET in 1 BOTTLE (75834-255-50)Marketed from Aug 26, 2020
75834-255-90	7583402559075834025590	90 TABLET in 1 BOTTLE (75834-255-90)Marketed from Aug 26, 2020

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): Atorvastatin calcium
Generic name (nonproprietary): atorvastatin calcium
Active ingredients: Atorvastatin — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: NIVAGEN PHARMACEUTICALS, INC.NDC labeler code 75834
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213853
Marketing start: Aug 26, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 75834-255_5cadacac-b574-c12a-e063-6394a90afd3cSPL ID 5cadacac-b574-c12a-e063-6394a90afd3c
Pharmacologic class: HMG-CoA Reductase Inhibitor

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

N475834025501 followed by a unit qualifier and the quantity

Package 75834-0255-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 75834-255

What is NDC 75834-255?: 75834-255 is the product NDC for Atorvastatin calcium, Atorvastatin 10 mg/1 tablet, listed with the FDA by NIVAGEN PHARMACEUTICALS, INC.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Atorvastatin calcium.
What is the active ingredient?: Atorvastatin.
Who is the labeler?: NIVAGEN PHARMACEUTICALS, INC., NDC labeler code 75834. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Atorvastatin calcium?: 389 other product NDCs are listed under this name. See all Atorvastatin calcium 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 Atorvastatin calcium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Atorvastatin calcium	Atorvastatin calcium trihydrate 40 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-979	60760-0979-30
Atorvastatin Calcium	Atorvastatin calcium trihydrate 80 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-0284	55154-0284-06
Atorvastatin Calcium	Atorvastatin calcium trihydrate 10 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-681	72189-0681-30
Atorvastatin Calcium	Atorvastatin calcium trihydrate 10 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals, Inc.	0480-3585	00480-3585-1000480-3585-98
Atorvastatin Calcium	Atorvastatin calcium propylene glycol solvate 40 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-013	87441-0013-01
Atorvastatin Calcium	Atorvastatin calcium trihydrate 20 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals, Inc.	0480-3586	00480-3586-1000480-3586-98
Atorvastatin Calcium	Atorvastatin calcium trihydrate 40 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals, Inc.	0480-3587	00480-3587-1000480-3587-98
Atorvastatin Calcium	Atorvastatin calcium trihydrate 10 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1677	67046-1677-03
Atorvastatin Calcium	Atorvastatin calcium trihydrate 80 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals, Inc.	0480-3588	00480-3588-1000480-3588-98
Atorvastatin Calcium	Atorvastatin calcium trihydrate 80 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1666	67046-1666-03

All 390 Atorvastatin calcium NDCs

Other NDCs under ANDA 213853

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

FDA NDC Directory listings under ANDA 213853
Product	Strength	Form · route	Labeler	Product NDC
Atorvastatin calcium	Atorvastatin 10 mg/1	TabletOral	Umedica Laboratories USA Inc.	60290-039
Atorvastatin calcium	Atorvastatin 20 mg/1	TabletOral	Umedica Laboratories USA Inc.	60290-040
Atorvastatin calcium	Atorvastatin 40 mg/1	TabletOral	Umedica Laboratories USA Inc.	60290-041
Atorvastatin calcium	Atorvastatin 80 mg/1	TabletOral	Umedica Laboratories USA Inc.	60290-042
Atorvastatin calcium	Atorvastatin 20 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-2967
Atorvastatin calcium	Atorvastatin 20 mg/1	TabletOral	REMEDYREPACK INC.	70518-3783
Atorvastatin calcium	Atorvastatin 80 mg/1	TabletOral	REMEDYREPACK INC.	70518-3848
Atorvastatin calcium	Atorvastatin 40 mg/1	TabletOral	REMEDYREPACK INC.	70518-4321
Atorvastatin calcium	Atorvastatin 20 mg/1	TabletOral	Bryant Ranch Prepack	71335-2213
Atorvastatin calcium	Atorvastatin 40 mg/1	TabletOral	Bryant Ranch Prepack	71335-2697
Atorvastatin calcium	Atorvastatin 80 mg/1	TabletOral	Bryant Ranch Prepack	71335-9646
Atorvastatin Calcium	Atorvastatin 20 mg/1	TabletOral	DirectRX	72189-291
Atorvastatin Calcium	Atorvastatin 10 mg/1	TabletOral	Direct_Rx	72189-531
Atorvastatin calcium	Atorvastatin 20 mg/1	TabletOral	NIVAGEN PHARMACEUTICALS, INC.	75834-256
Atorvastatin calcium	Atorvastatin 40 mg/1	TabletOral	NIVAGEN PHARMACEUTICALS, INC.	75834-257
Atorvastatin calcium	Atorvastatin 80 mg/1	TabletOral	NIVAGEN PHARMACEUTICALS, INC.	75834-258
Atorvastatin calcium	Atorvastatin 40 mg/1	TabletOral	Proficient Rx LP	82804-056