What is NDC 70377-001?

70377-001 is the product NDC for Simvastatin, Simvastatin 5 mg/1 tablet, film coated, listed with the FDA by Biocon Pharma Inc,. It has 4 package NDCs, shown above in 10- and 11-digit form.

Biocon Pharma Inc,, NDC labeler code 70377. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Simvastatin?

156 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Simvastatin NDC 70377-001 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70377-001Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70377-0001Add 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 NDC	11-digit (billing)	Package
70377-001-12	7037700011270377000112	30 TABLET, FILM COATED in 1 BOTTLE (70377-001-12)Marketed from Dec 17, 2015
70377-001-13	7037700011370377000113	45 TABLET, FILM COATED in 1 BOTTLE (70377-001-13)Marketed from Dec 17, 2015
70377-001-14	7037700011470377000114	90 TABLET, FILM COATED in 1 BOTTLE (70377-001-14)Marketed from Dec 17, 2015
70377-001-15	7037700011570377000115	1000 TABLET, FILM COATED in 1 BOTTLE (70377-001-15)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 — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Biocon Pharma Inc,NDC labeler code 70377
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078034
Marketing start: Dec 17, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 70377-001_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

N470377000112 followed by a unit qualifier and the quantity

Package 70377-0001-12. 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 Sep 26, 2023.

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)

About NDC 70377-001

What is NDC 70377-001?: 70377-001 is the product NDC for Simvastatin, Simvastatin 5 mg/1 tablet, film coated, listed with the FDA by Biocon Pharma Inc,. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Simvastatin.
What is the active ingredient?: Simvastatin.
Who is the labeler?: Biocon Pharma Inc,, NDC labeler code 70377. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Simvastatin?: 156 other product NDCs are listed under this name. See all Simvastatin NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Simvastatin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0628	67046-0628-03
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0626	67046-0626-03
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0542	67046-0542-03
Simvastatin	Simvastatin 5 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-305	72865-0305-0172865-0305-1072865-0305-30+1 more
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-306	72865-0306-0172865-0306-1072865-0306-30+1 more
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-307	72865-0307-0172865-0307-1072865-0307-30+2 more
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-308	72865-0308-0172865-0308-1072865-0308-30+2 more
Simvastatin	Simvastatin 80 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-309	72865-0309-0172865-0309-0572865-0309-10+3 more
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	Westminster Pharmaceuticals, LLC	69367-376	69367-0376-0969367-0376-10
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	Westminster Pharmaceuticals, LLC	69367-374	69367-0374-0969367-0374-10

All 157 Simvastatin NDCs

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
Product	Strength	Form · route	Labeler	Product NDC
Simvastatin	Simvastatin 5 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6459
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-113
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-448
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	53401-013
Simvastatin	Simvastatin 80 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	53401-018
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	53401-026
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	Biocon Pharma Inc,	70377-002
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	Biocon Pharma Inc,	70377-003
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	Biocon Pharma Inc,	70377-004
Simvastatin	Simvastatin 80 mg/1	Tablet, Film coatedOral	Biocon Pharma Inc,	70377-005
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3630
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3648
Simvastatin	Simvastatin 5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4102
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1891
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1905
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1906
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-609
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-610
Simvastatin	Simvastatin 80 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-611
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-615

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