Prescription drug · NDA AUTHORIZED GENERIC
Amlodipine and Atorvastatin NDC 66993-268
Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 40 mg/1 · Tablet, Coated · Oral · Prasco Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66993-268-30 | 66993026830 | 30 TABLET, COATED in 1 BOTTLE (66993-268-30)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 — 5 mg/1Atorvastatin calcium trihydrate — 40 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Prasco LaboratoriesNDC labeler code 66993
- 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 66993-268_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
N466993026830followed by a unit qualifier and the quantityPackage 66993-0268-30. 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.
About NDC 66993-268
- What is NDC 66993-268?
- 66993-268 is the product NDC for Amlodipine and Atorvastatin, Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 40 mg/1 tablet, coated, listed with the FDA by Prasco Laboratories. 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?
- Prasco Laboratories, NDC labeler code 66993. 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.
Related NDCs: other Amlodipine and Atorvastatin products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 Limited | 46708-755 | 46708-0755-3046708-0755-90 |
| Amlodipine and Atorvastatin | Amlodipine besylate 2.5 mg/1; Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-756 | 46708-0756-3046708-0756-90 |
| Amlodipine and Atorvastatin | Amlodipine besylate 2.5 mg/1; Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-757 | 46708-0757-3046708-0757-90 |
| Amlodipine and Atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-758 | 46708-0758-3046708-0758-90 |
| Amlodipine and Atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-759 | 46708-0759-3046708-0759-90 |
| Amlodipine and Atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-760 | 46708-0760-3046708-0760-90 |
| Amlodipine and Atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-761 | 46708-0761-3046708-0761-90 |
| Amlodipine and Atorvastatin | Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-762 | 46708-0762-3046708-0762-90 |
| Amlodipine and Atorvastatin | Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-763 | 46708-0763-3046708-0763-90 |
| Amlodipine and Atorvastatin | Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-764 | 46708-0764-3046708-0764-90 |
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 |
|---|---|---|---|---|
| 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 2.5 mg/1; Atorvastatin calcium trihydrate 40 mg/1 | Tablet, CoatedOral | Prasco Laboratories | 66993-265 |
| 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 80 mg/1 | Tablet, CoatedOral | Prasco Laboratories | 66993-269 |
| 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 |
| 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 5 mg/1; Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-6180 |
| Caduetamlodipine and atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-6323 |
| Caduetamlodipine and atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-6565 |
| Caduetamlodipine and atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-6747 |
| Caduetamlodipine and atorvastatin | Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-7232 |
| 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 40 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-7654 |
| Caduetamlodipine and atorvastatin | Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-7810 |
| Caduetamlodipine and atorvastatin | Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-060 |
| Caduetamlodipine and atorvastatin | Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-061 |
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