What is NDC 71205-192?

71205-192 is the product NDC for Simvastatin, Simvastatin 40 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 71205. 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?

155 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 71205-192 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71205-192Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71205-0192Add 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
71205-192-30	71205019230	30 TABLET, FILM COATED in 1 BOTTLE (71205-192-30)Marketed from Jan 1, 2019
71205-192-60	71205019260	60 TABLET, FILM COATED in 1 BOTTLE (71205-192-60)Marketed from Jan 1, 2019
71205-192-90	71205019290	90 TABLET, FILM COATED in 1 BOTTLE (71205-192-90)Marketed from Jan 1, 2019

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 — 40 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Proficient Rx LPNDC labeler code 71205
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078103
Marketing start: Dec 2, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 71205-192_3cd63811-b40d-47c5-9c50-c0a30bc68fccSPL ID 3cd63811-b40d-47c5-9c50-c0a30bc68fccSPL set ID 7649bec7-04c6-47b5-a050-15923006dac0RxCUI 198211UNII AGG2FN16EVUPC 0371205192303
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

N471205019230 followed by a unit qualifier and the quantity

Package 71205-0192-30. 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 Apr 1, 2022.

Indications (excerpt from the label)

Simvastatin tablets USP are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: • Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events. ( 1.1 ) • Reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. ( 1.2 ) • Reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia. ( 1.2 ) • Reduce total-C and LDL-C in adult patients w…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71205-192

What is NDC 71205-192?: 71205-192 is the product NDC for Simvastatin, Simvastatin 40 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 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?: Proficient Rx LP, NDC labeler code 71205. 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?: 155 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 20 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0626	67046-0626-03
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0628	67046-0628-03
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0542	67046-0542-03
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-308	72865-0308-0172865-0308-1072865-0308-30+2 more
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 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 80 mg/1	Tablet, Film coatedOral	Westminster Pharmaceuticals, LLC	69367-377	69367-0377-0969367-0377-10

All 156 Simvastatin NDCs

Other NDCs under ANDA 078103

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

FDA NDC Directory listings under ANDA 078103
Product	Strength	Form · route	Labeler	Product NDC
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4331
Simvastatin	Simvastatin 80 mg/1	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	68180-465
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6236
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-7992
Simvastatin	Simvastatin 80 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals, Inc.	68788-8406
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-387
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-7993
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-798
Simvastatin	Simvastatin 80 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-5788
Simvastatin	Simvastatin 80 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-9717
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-809
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-966
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	68180-464
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6306
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6307
Simvastatin	Simvastatin 80 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-580
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	68180-479
Simvastatin	Simvastatin 5 mg/1	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	68180-482
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-585
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-459

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