Prescription drug · ANDA

Amlodipine besylate and Atorvastatin calcium NDC 43598-313

Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 80 mg/1 · Tablet, Film coated · Oral · Dr. Reddy's Laboratories Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)43598-313Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43598-0313Add 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
43598-313-0543598031305500 TABLET, FILM COATED in 1 BOTTLE (43598-313-05)Marketed from Mar 17, 2014
43598-313-304359803133030 TABLET, FILM COATED in 1 BOTTLE (43598-313-30)Marketed from Mar 17, 2014
43598-313-604359803136060 TABLET, FILM COATED in 1 BOTTLE (43598-313-60)Marketed from Mar 17, 2014
43598-313-904359803139090 TABLET, FILM COATED in 1 BOTTLE (43598-313-90)Marketed from Mar 17, 2014

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 besylate and Atorvastatin calcium
Generic name (nonproprietary)
amlodipine besylate and atorvastatin calcium
Active ingredients
Amlodipine besylate — 10 mg/1Atorvastatin calcium trihydrate — 80 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203874
Marketing start
Listing expires
Other FDA classes
Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 43598-313_54058ac6-94e2-d2d3-5c46-886b3478fc76SPL ID 54058ac6-94e2-d2d3-5c46-886b3478fc76SPL set ID abee4a34-89cc-d886-192c-32582ab8f024RxCUI 404011, 404013, 597967, 597971, 597974, 597977, 597980, 597984, 597987, 597990, 597993UNII 864V2Q084H, 48A5M73Z4QUPC 0343598323305, 0343598315300, 0343598320304, 0343598317304, 0343598313306, 0343598322308, 0343598319308, 0343598316307, 0343598314303
Pharmacologic class
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

N443598031305 followed by a unit qualifier and the quantity

Package 43598-0313-05. 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)

Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine Amlodipine besylate and atorvastatin calcium tablets are a combination of amlodipine besylate, a calcium channel blocker, and atorvastatin calcium, a HMG CoA-reductase inhibitor, indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine is indicated for the treatment of hypertension, to lower blood pressure (1.1). Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Amlodipine is indicated for the treatment…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203874

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

FDA NDC Directory listings under ANDA 203874
ProductStrengthForm · routeLabelerProduct NDC
Amlodipine besylate and Atorvastatin calciumAmlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 20 mg/1Tablet, Film coatedOralDr. Reddy's Laboratories Inc43598-319
Amlodipine besylate and Atorvastatin calciumAmlodipine besylate 2.5 mg/1; Atorvastatin calcium trihydrate 20 mg/1Tablet, Film coatedOralDr. Reddy's Laboratories Inc43598-320
Amlodipine besylate and Atorvastatin calciumAmlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 10 mg/1Tablet, Film coatedOralDr. Reddy's Laboratories Inc43598-321
Amlodipine besylate and Atorvastatin calciumAmlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 10 mg/1Tablet, Film coatedOralDr. Reddy's Laboratories Inc43598-322
Amlodipine besylate and Atorvastatin calciumAmlodipine besylate 2.5 mg/1; Atorvastatin calcium trihydrate 10 mg/1Tablet, Film coatedOralDr. Reddy's Laboratories Inc43598-323
Amlodipine besylate and Atorvastatin calciumAmlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 80 mg/1Tablet, Film coatedOralDr. Reddy's Laboratories Inc43598-314
Amlodipine besylate and Atorvastatin calciumAmlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 20 mg/1Tablet, Film coatedOralDr. Reddy's Laboratories Inc43598-318
Amlodipine besylate and Atorvastatin calciumAmlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 40 mg/1Tablet, Film coatedOralDr. Reddy's Laboratories Inc43598-315
Amlodipine besylate and Atorvastatin calciumAmlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 40 mg/1Tablet, Film coatedOralDr. Reddy's Laboratories Inc43598-316
Amlodipine besylate and Atorvastatin calciumAmlodipine besylate 2.5 mg/1; Atorvastatin calcium trihydrate 40 mg/1Tablet, Film coatedOralDr. Reddy's Laboratories Inc43598-317

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Amlodipine besylate and Atorvastatin calcium NDC 43598-313 | Med-Code