What is NDC 60505-3478?

60505-3478 is the product NDC for Amlodipine and Atorvastatin, Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 10 mg/1 tablet, film coated, listed with the FDA by Apotex Corp.. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Amlodipine besylate, Atorvastatin calcium trihydrate.

Apotex Corp., NDC labeler code 60505. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Amlodipine and Atorvastatin?

55 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Amlodipine and Atorvastatin NDC 60505-3478

NDC codes

FDA NDC Directory

Product NDC (as listed)60505-3478Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60505-3478Add 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
60505-3478-3	60505347803	30 TABLET, FILM COATED in 1 BOTTLE (60505-3478-3)Marketed from Jul 29, 2020

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

Brand name (proprietary): Amlodipine and Atorvastatin
Generic name (nonproprietary): amlodipine and atorvastatin
Active ingredients: Amlodipine besylate — 5 mg/1Atorvastatin calcium trihydrate — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Apotex Corp.NDC labeler code 60505
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205199
Marketing start: Jul 29, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 60505-3478_f3607a61-82ce-eafc-1ee7-6eb7ad04fb8bSPL ID f3607a61-82ce-eafc-1ee7-6eb7ad04fb8bSPL set ID 4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03RxCUI 404011, 404013, 597967, 597977, 597980, 597984, 597987, 597990UNII 864V2Q084H, 48A5M73Z4QUPC 0360505347933, 0360505349333, 0360505348930, 0360505348435, 0360505348336, 0360505347834
Pharmacologic class: Calcium Channel Blocker; Dihydropyridine Calcium Channel Blocker; 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

N460505347803 followed by a unit qualifier and the quantity

Package 60505-3478-03. 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 Sep 3, 2026.

Indications (excerpt from the label)

Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine Hypertension Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 60505-3478

What is NDC 60505-3478?: 60505-3478 is the product NDC for Amlodipine and Atorvastatin, Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 10 mg/1 tablet, film coated, listed with the FDA by Apotex Corp.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Amlodipine and Atorvastatin.
What is the active ingredient?: Amlodipine besylate, Atorvastatin calcium trihydrate.
Who is the labeler?: Apotex Corp., NDC labeler code 60505. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Amlodipine and Atorvastatin?: 55 other product NDCs are listed under this name. See all Amlodipine and Atorvastatin 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 Amlodipine and Atorvastatin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Amlodipine and Atorvastatin	Amlodipine besylate 2.5 mg/1; Atorvastatin calcium trihydrate 10 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-755	62332-0755-3062332-0755-90
Amlodipine and Atorvastatin	Amlodipine besylate 2.5 mg/1; Atorvastatin calcium trihydrate 20 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-756	62332-0756-3062332-0756-90
Amlodipine and Atorvastatin	Amlodipine besylate 2.5 mg/1; Atorvastatin calcium trihydrate 40 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-757	62332-0757-3062332-0757-90
Amlodipine and Atorvastatin	Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 10 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-758	62332-0758-3062332-0758-90
Amlodipine and Atorvastatin	Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 20 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-759	62332-0759-3062332-0759-90
Amlodipine and Atorvastatin	Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 40 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-760	62332-0760-3062332-0760-90
Amlodipine and Atorvastatin	Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 80 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-761	62332-0761-3062332-0761-90
Amlodipine and Atorvastatin	Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 10 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-762	62332-0762-3062332-0762-90
Amlodipine and Atorvastatin	Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 20 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-763	62332-0763-3062332-0763-90
Amlodipine and Atorvastatin	Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 40 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-764	62332-0764-3062332-0764-90

All 56 Amlodipine and Atorvastatin NDCs

Other NDCs under ANDA 205199

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

FDA NDC Directory listings under ANDA 205199
Product	Strength	Form · route	Labeler	Product NDC
Amlodipine and Atorvastatin	Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 10 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-3479
Amlodipine and Atorvastatin	Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 20 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-3483
Amlodipine and Atorvastatin	Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 20 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-3484
Amlodipine and Atorvastatin	Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 40 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-3488
Amlodipine and Atorvastatin	Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 40 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-3489
Amlodipine and Atorvastatin	Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 80 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-3492
Amlodipine and Atorvastatin	Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 80 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-3493
Amlodipine and Atorvastatin	Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2924
Amlodipine and Atorvastatin	Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-3076
Amlodipine and Atorvastatin	Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 20 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2090
Amlodipine and Atorvastatin	Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 40 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2091
Amlodipine and Atorvastatin	Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2092
Amlodipine and Atorvastatin	Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 20 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2093
Amlodipine and Atorvastatin	Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 40 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2094