NDC codes

FDA NDC Directory
Product NDC (as listed)16714-009Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0009Add 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
16714-009-011671400090116714000901100 TABLET in 1 BOTTLE (16714-009-01)Marketed from May 1, 2020

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)
Isosorbide dinitrate
Generic name (nonproprietary)
isosorbide dinitrate
Active ingredients
Isosorbide dinitrate — 20 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Northstar Rx LLCNDC labeler code 16714
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213057
Marketing start
Listing expires
Other FDA classes
Nitrates (Chemical structure)Vasodilation (Physiologic effect)
Identifiers
Product ID 16714-009_be0de7ff-f8d9-472f-a35c-252a2cf16954SPL ID be0de7ff-f8d9-472f-a35c-252a2cf16954SPL set ID 246c749d-aa28-44ce-8d42-984660afff2aRxCUI 197839, 206842, 314055, 381056UNII IA7306519N
Pharmacologic class
Nitrate Vasodilator

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

N416714000901 followed by a unit qualifier and the quantity

Package 16714-0009-01. 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)

INDICATIONS AND USAGE Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16714-009

What is NDC 16714-009?
16714-009 is the product NDC for Isosorbide dinitrate, Isosorbide dinitrate 20 mg/1 tablet, listed with the FDA by Northstar Rx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Isosorbide dinitrate.
What is the active ingredient?
Isosorbide dinitrate.
Who is the labeler?
Northstar Rx LLC, NDC labeler code 16714. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Isosorbide dinitrate?
51 other product NDCs are listed under this name. See all Isosorbide dinitrate 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 Isosorbide dinitrate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Isosorbide DinitrateIsosorbide dinitrate 10 mg/1TabletOralREMEDYREPACK INC.70518-440570518-4405-00
Isosorbide dinitrateIsosorbide dinitrate 30 mg/1TabletOralBluePoint Laboratories68001-56268001-0562-00
Isosorbide DinitrateIsosorbide dinitrate 10 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-846300615-8463-39
Isosorbide DinitrateIsosorbide dinitrate 20 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-846400615-8464-39
Isosorbide DinitrateIsosorbide dinitrate 30 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-846500615-8465-39
Isosorbide DinitrateIsosorbide dinitrate 5 mg/1TabletOralAdvagen Pharma Ltd72888-08172888-0081-0072888-0081-01
Isosorbide DinitrateIsosorbide dinitrate 10 mg/1TabletOralAdvagen Pharma Ltd72888-08272888-0082-0072888-0082-01
Isosorbide DinitrateIsosorbide dinitrate 20 mg/1TabletOralAdvagen Pharma Ltd72888-08372888-0083-0072888-0083-01
Isosorbide DinitrateIsosorbide dinitrate 30 mg/1TabletOralAdvagen Pharma Ltd72888-08472888-0084-0072888-0084-01
Isosorbide DinitrateIsosorbide dinitrate 40 mg/1TabletOralAdvagen Pharma Ltd72888-08572888-0085-0072888-0085-01

All 52 Isosorbide dinitrate NDCs

Other NDCs under ANDA 213057

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

FDA NDC Directory listings under ANDA 213057
ProductStrengthForm · routeLabelerProduct NDC
Isosorbide dinitrateIsosorbide dinitrate 5 mg/1TabletOralNorthstar Rx LLC16714-007
Isosorbide dinitrateIsosorbide dinitrate 10 mg/1TabletOralNorthstar Rx LLC16714-008
Isosorbide dinitrateIsosorbide dinitrate 30 mg/1TabletOralNorthstar Rx LLC16714-010
Isosorbide dinitrateIsosorbide dinitrate 30 mg/1TabletOralBluePoint Laboratories68001-562
Isosorbide dinitrateIsosorbide dinitrate 5 mg/1TabletOralZydus Pharmaceuticals (USA) Inc.70710-1148
Isosorbide dinitrateIsosorbide dinitrate 10 mg/1TabletOralZydus Pharmaceuticals (USA) Inc.70710-1149
Isosorbide dinitrateIsosorbide dinitrate 20 mg/1TabletOralZydus Pharmaceuticals (USA) Inc.70710-1150
Isosorbide dinitrateIsosorbide dinitrate 30 mg/1TabletOralZydus Pharmaceuticals (USA) Inc.70710-1151
Isosorbide dinitrateIsosorbide dinitrate 40 mg/1TabletOralZydus Pharmaceuticals (USA) Inc.70710-1152
Isosorbide dinitrateIsosorbide dinitrate 5 mg/1TabletOralZydus Lifesciences Limited70771-1501
Isosorbide dinitrateIsosorbide dinitrate 10 mg/1TabletOralZydus Lifesciences Limited70771-1502
Isosorbide dinitrateIsosorbide dinitrate 20 mg/1TabletOralZydus Lifesciences Limited70771-1503
Isosorbide dinitrateIsosorbide dinitrate 30 mg/1TabletOralZydus Lifesciences Limited70771-1504
Isosorbide dinitrateIsosorbide dinitrate 40 mg/1TabletOralZydus Lifesciences Limited70771-1505

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