Prescription drug · ANDA

Simvastatin NDC 70377-003

Simvastatin 20 mg/1 · Tablet, Film coated · Oral · Biocon Pharma Inc,

NDC codes

FDA NDC Directory
Product NDC (as listed)70377-003Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70377-0003Add 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
70377-003-127037700031230 TABLET, FILM COATED in 1 BOTTLE (70377-003-12)Marketed from Dec 17, 2015
70377-003-137037700031345 TABLET, FILM COATED in 1 BOTTLE (70377-003-13)Marketed from Dec 17, 2015
70377-003-147037700031490 TABLET, FILM COATED in 1 BOTTLE (70377-003-14)Marketed from Dec 17, 2015
70377-003-15703770003151000 TABLET, FILM COATED in 1 BOTTLE (70377-003-15)Marketed from Dec 17, 2015

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)
Simvastatin
Generic name (nonproprietary)
simvastatin
Active ingredients
Simvastatin — 20 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078034
Marketing start
Listing expires
Other FDA classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 70377-003_4d832ba0-8b5c-de5a-246a-a5f30e884bb4SPL ID 4d832ba0-8b5c-de5a-246a-a5f30e884bb4SPL set ID 7b325108-6940-50a7-96b4-822a5206e568RxCUI 198211, 200345, 312961, 312962, 314231UNII AGG2FN16EV
Pharmacologic class
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

N470377000312 followed by a unit qualifier and the quantity

Package 70377-0003-12. 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)

Simvastatin tablets are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to redu…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078034

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

FDA NDC Directory listings under ANDA 078034
ProductStrengthForm · routeLabelerProduct NDC
SimvastatinSimvastatin 5 mg/1Tablet, Film coatedOralBiocon Pharma Inc,70377-001
SimvastatinSimvastatin 80 mg/1Tablet, Film coatedOralBiocon Pharma Inc,70377-005
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralBiocon Pharma Inc,70377-002
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralBiocon Pharma Inc,70377-004
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-113
SimvastatinSimvastatin 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6459
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1891
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-609
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-610
SimvastatinSimvastatin 80 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-611
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-615
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1906
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1905
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-622
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-623
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.84677-015
SimvastatinSimvastatin 5 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.84677-014
SimvastatinSimvastatin 80 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.84677-018
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.84677-016
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.84677-017

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Simvastatin NDC 70377-003 | Med-Code