Prescription drug · NDA
Caduet (Amlodipine and atorvastatin) NDC 0069-6323
Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 20 mg/1 · Tablet, Film coated · Oral · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0069-6323-30 | 00069632330 | 30 TABLET, FILM COATED in 1 BOTTLE (0069-6323-30)Marketed from Aug 31, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Caduet
- Generic name (nonproprietary)
- amlodipine and atorvastatin
- Active ingredients
- Amlodipine besylate — 5 mg/1Atorvastatin calcium trihydrate — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Pfizer Laboratories Div Pfizer IncNDC labeler code 0069
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication 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 0069-6323_7df1ff98-e490-4df8-8631-b21dc94a396eSPL ID 7df1ff98-e490-4df8-8631-b21dc94a396eSPL set ID 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6RxCUI 404011, 404013, 597967, 597977, 597980, 597984, 597987, 597990, 750199, 750203, 750207, 750211, 750227, 750231, 750235, 750239UNII 48A5M73Z4Q, 864V2Q084HUPC 0300692150305, 0300692250302, 0300692170303, 0300692160304, 0300692190301, 0300696565303, 0300696747303, 0300697810303, 0300692270300, 0300697232303, 0300697476301, 0300696180308, 0300696323309, 0300692260301, 0300697654303
- 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
N400069632330followed by a unit qualifier and the quantityPackage 00069-6323-30. 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)
CADUET (amlodipine and atorvastatin) is indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. CADUET is a combination of amlodipine besylate, a calcium channel blocker, and atorvastatin calcium, a HMG-CoA-reductase inhibitor (statin), indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate ( 1 ). 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. Amlodipine is indicated for the treatment of Coronary Artery Disease ( 1 ). Atorvastatin is indicated ( 1 …
Excerpt only. Read the full label for complete information.
About NDC 0069-6323
- What is NDC 0069-6323?
- 0069-6323 is the product NDC for Caduet, Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 20 mg/1 tablet, film coated, listed with the FDA by Pfizer Laboratories Div Pfizer Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Caduet (Amlodipine and atorvastatin).
- What is the active ingredient?
- Amlodipine besylate, Atorvastatin calcium trihydrate.
- Who is the labeler?
- Pfizer Laboratories Div Pfizer Inc, NDC labeler code 0069. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Caduet?
- 13 other product NDCs are listed under this name. See all Caduet NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Caduet products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Caduetamlodipine and atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-064 | 58151-0064-93 |
| Caduetamlodipine and atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-066 | 58151-0066-93 |
| Caduetamlodipine and atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-067 | 58151-0067-93 |
| Caduetamlodipine and atorvastatin | Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-062 | 58151-0062-93 |
| Caduetamlodipine and atorvastatin | Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-063 | 58151-0063-93 |
| Caduetamlodipine and atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-065 | 58151-0065-93 |
| Caduetamlodipine and atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-6747 | 00069-6747-30 |
| Caduetamlodipine and atorvastatin | Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-7476 | 00069-7476-30 |
| Caduetamlodipine and atorvastatin | Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-7654 | 00069-7654-30 |
| Caduetamlodipine and atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-6180 | 00069-6180-30 |
Other NDCs under NDA 021540
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Caduetamlodipine and atorvastatin | Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-7476 |
| Caduetamlodipine and atorvastatin | Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-7810 |
| Amlodipine and Atorvastatin | Amlodipine besylate 2.5 mg/1; Atorvastatin calcium trihydrate 40 mg/1 | Tablet, CoatedOral | Prasco Laboratories | 66993-265 |
| Amlodipine and Atorvastatin | Amlodipine besylate 2.5 mg/1; Atorvastatin calcium trihydrate 10 mg/1 | Tablet, CoatedOral | Prasco Laboratories | 66993-263 |
| Amlodipine and Atorvastatin | Amlodipine besylate 2.5 mg/1; Atorvastatin calcium trihydrate 20 mg/1 | Tablet, CoatedOral | Prasco Laboratories | 66993-264 |
| Amlodipine and Atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 80 mg/1 | Tablet, CoatedOral | Prasco Laboratories | 66993-269 |
| Amlodipine and Atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 10 mg/1 | Tablet, CoatedOral | Prasco Laboratories | 66993-266 |
| Amlodipine and Atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 20 mg/1 | Tablet, CoatedOral | Prasco Laboratories | 66993-267 |
| Amlodipine and Atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 40 mg/1 | Tablet, CoatedOral | Prasco Laboratories | 66993-268 |
| Amlodipine and Atorvastatin | Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 10 mg/1 | Tablet, CoatedOral | Prasco Laboratories | 66993-270 |
| Amlodipine and Atorvastatin | Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 20 mg/1 | Tablet, CoatedOral | Prasco Laboratories | 66993-271 |
| Amlodipine and Atorvastatin | Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 40 mg/1 | Tablet, CoatedOral | Prasco Laboratories | 66993-272 |
| Caduetamlodipine and atorvastatin | Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-063 |
| Amlodipine and Atorvastatin | Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 80 mg/1 | Tablet, CoatedOral | Prasco Laboratories | 66993-273 |
| Caduetamlodipine and atorvastatin | Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-062 |
| Caduetamlodipine and atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-067 |
| Caduetamlodipine and atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-064 |
| Caduetamlodipine and atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-065 |
| Caduetamlodipine and atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-066 |
| Caduetamlodipine and atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-6747 |
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