NDC codes

FDA NDC Directory
Product NDC (as listed)63304-830Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63304-0830Add 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
63304-830-056330408300563304083005500 TABLET, FILM COATED in 1 BOTTLE (63304-830-05)Marketed from Dec 1, 2011
63304-830-90633040830906330408309090 TABLET, FILM COATED in 1 BOTTLE (63304-830-90)Marketed from Dec 1, 2011

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 calcium trihydrate — 80 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Sun Pharmaceutical Industries Inc.NDC labeler code 63304
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076477
Marketing start
Listing expires
Other FDA classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 63304-830_536bd509-870a-5525-e063-6294a90a86cfSPL ID 536bd509-870a-5525-e063-6294a90a86cfSPL set ID 595ab888-6b55-4642-a32f-e8521821ed81RxCUI 259255, 617310, 617311, 617312UNII 48A5M73Z4Q
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

N463304083005 followed by a unit qualifier and the quantity

Package 63304-0830-05. 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)

Atorvastatin calcium tablets are indicated: • To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD • As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63304-830

What is NDC 63304-830?
63304-830 is the product NDC for Atorvastatin Calcium, Atorvastatin calcium trihydrate 80 mg/1 tablet, film coated, listed with the FDA by Sun Pharmaceutical Industries Inc.. It has 2 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 calcium trihydrate.
Who is the labeler?
Sun Pharmaceutical Industries Inc., NDC labeler code 63304. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Atorvastatin calciumAtorvastatin calcium trihydrate 40 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-97960760-0979-30
Atorvastatin CalciumAtorvastatin calcium trihydrate 80 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-028455154-0284-06
Atorvastatin CalciumAtorvastatin calcium trihydrate 10 mg/1Tablet, Film coatedOralDirect_Rx72189-68172189-0681-30
Atorvastatin CalciumAtorvastatin calcium trihydrate 10 mg/1Tablet, Film coatedOralTeva Pharmaceuticals, Inc.0480-358500480-3585-1000480-3585-98
Atorvastatin CalciumAtorvastatin calcium propylene glycol solvate 40 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-01387441-0013-01
Atorvastatin CalciumAtorvastatin calcium trihydrate 20 mg/1Tablet, Film coatedOralTeva Pharmaceuticals, Inc.0480-358600480-3586-1000480-3586-98
Atorvastatin CalciumAtorvastatin calcium trihydrate 40 mg/1Tablet, Film coatedOralTeva Pharmaceuticals, Inc.0480-358700480-3587-1000480-3587-98
Atorvastatin CalciumAtorvastatin calcium trihydrate 10 mg/1Tablet, Film coatedOralCoupler LLC67046-167767046-1677-03
Atorvastatin CalciumAtorvastatin calcium trihydrate 80 mg/1Tablet, Film coatedOralTeva Pharmaceuticals, Inc.0480-358800480-3588-1000480-3588-98
Atorvastatin CalciumAtorvastatin calcium trihydrate 80 mg/1Tablet, Film coatedOralCoupler LLC67046-166667046-1666-03

All 390 Atorvastatin Calcium NDCs

Other NDCs under ANDA 076477

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

FDA NDC Directory listings under ANDA 076477
ProductStrengthForm · routeLabelerProduct NDC
Atorvastatin CalciumAtorvastatin calcium trihydrate 40 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries Inc.63304-829
Atorvastatin CalciumAtorvastatin calcium trihydrate 80 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-2276
Atorvastatin CalciumAtorvastatin calcium trihydrate 20 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-2824
Atorvastatin CalciumAtorvastatin calcium trihydrate 40 mg/1Tablet, Film coatedOralProficient Rx LP71205-264
Atorvastatin CalciumAtorvastatin calcium trihydrate 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1010
Atorvastatin CalciumAtorvastatin calcium trihydrate 40 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1011
Atorvastatin CalciumAtorvastatin calcium trihydrate 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1710
Atorvastatin CalciumAtorvastatin calcium trihydrate 10 mg/1Tablet, Film coatedOralDIRECT RX72189-226

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