Prescription drug · NDA AUTHORIZED GENERIC

Amlodipine and Atorvastatin NDC 66993-265

Amlodipine besylate 2.5 mg/1; Atorvastatin calcium trihydrate 40 mg/1 · Tablet, Coated · Oral · Prasco Laboratories

NDC codes

FDA NDC Directory
Product NDC (as listed)66993-265Labeler and product segments. Claims need a package NDC.
Product NDC at billing width66993-0265Add 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
66993-265-306699302653030 TABLET, COATED in 1 BOTTLE (66993-265-30)Marketed from Mar 14, 2022

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)
Amlodipine and Atorvastatin
Generic name (nonproprietary)
amlodipine and atorvastatin
Active ingredients
Amlodipine besylate — 2.5 mg/1Atorvastatin calcium trihydrate — 40 mg/1
Dosage form
Tablet, Coated
Route
Oral
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 021540
Marketing start
Listing expires
Other FDA classes
Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 66993-265_c09c6dd4-0101-4551-878c-f28080948160SPL ID c09c6dd4-0101-4551-878c-f28080948160SPL set ID 14124e56-77ba-426d-8f5a-dbe42eda1a20RxCUI 404011, 404013, 597967, 597971, 597974, 597977, 597980, 597984, 597987, 597990, 597993UNII 864V2Q084H, 48A5M73Z4QUPC 0366993265308, 0366993267302, 0366993264301, 0366993268309, 0366993263304, 0366993273303, 0366993272306, 0366993271309, 0366993266305, 0366993269306, 0366993270302
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

N466993026530 followed by a unit qualifier and the quantity

Package 66993-0265-30. 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)

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)

Other NDCs under NDA 021540

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

FDA NDC Directory listings under NDA 021540
ProductStrengthForm · routeLabelerProduct NDC
Caduetamlodipine and atorvastatinAmlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 10 mg/1Tablet, Film coatedOralPfizer Laboratories Div Pfizer Inc0069-6180
Caduetamlodipine and atorvastatinAmlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 20 mg/1Tablet, Film coatedOralPfizer Laboratories Div Pfizer Inc0069-7232
Caduetamlodipine and atorvastatinAmlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 40 mg/1Tablet, Film coatedOralPfizer Laboratories Div Pfizer Inc0069-6565
Caduetamlodipine and atorvastatinAmlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 10 mg/1Tablet, Film coatedOralPfizer Laboratories Div Pfizer Inc0069-7810
Caduetamlodipine and atorvastatinAmlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 80 mg/1Tablet, Film coatedOralPfizer Laboratories Div Pfizer Inc0069-7476
Amlodipine and AtorvastatinAmlodipine besylate 2.5 mg/1; Atorvastatin calcium trihydrate 20 mg/1Tablet, CoatedOralPrasco Laboratories66993-264
Amlodipine and AtorvastatinAmlodipine besylate 2.5 mg/1; Atorvastatin calcium trihydrate 10 mg/1Tablet, CoatedOralPrasco Laboratories66993-263
Amlodipine and AtorvastatinAmlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 20 mg/1Tablet, CoatedOralPrasco Laboratories66993-267
Amlodipine and AtorvastatinAmlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 10 mg/1Tablet, CoatedOralPrasco Laboratories66993-266
Amlodipine and AtorvastatinAmlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 20 mg/1Tablet, CoatedOralPrasco Laboratories66993-271
Amlodipine and AtorvastatinAmlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 40 mg/1Tablet, CoatedOralPrasco Laboratories66993-268
Caduetamlodipine and atorvastatinAmlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 80 mg/1Tablet, Film coatedOralPfizer Laboratories Div Pfizer Inc0069-6747
Amlodipine and AtorvastatinAmlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 80 mg/1Tablet, CoatedOralPrasco Laboratories66993-269
Amlodipine and AtorvastatinAmlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 10 mg/1Tablet, CoatedOralPrasco Laboratories66993-270
Caduetamlodipine and atorvastatinAmlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 10 mg/1Tablet, Film coatedOralViatris Specialty LLC58151-064
Amlodipine and AtorvastatinAmlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 40 mg/1Tablet, CoatedOralPrasco Laboratories66993-272
Caduetamlodipine and atorvastatinAmlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 40 mg/1Tablet, Film coatedOralViatris Specialty LLC58151-062
Amlodipine and AtorvastatinAmlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 80 mg/1Tablet, CoatedOralPrasco Laboratories66993-273
Caduetamlodipine and atorvastatinAmlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 80 mg/1Tablet, Film coatedOralViatris Specialty LLC58151-063
Caduetamlodipine and atorvastatinAmlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 20 mg/1Tablet, Film coatedOralViatris Specialty LLC58151-065

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Amlodipine and Atorvastatin NDC 66993-265 | Med-Code