NDC codes

FDA NDC Directory
Product NDC (as listed)50268-447Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50268-0447Add 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
50268-447-15502680447155026804471550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-447-15) / 1 TABLET in 1 BLISTER PACK (50268-447-11)Marketed from Sep 13, 2016

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 — 5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
AvPAKNDC labeler code 50268
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 086923
Marketing start
Listing expires
Other FDA classes
Nitrates (Chemical structure)Vasodilation (Physiologic effect)
Identifiers
Product ID 50268-447_4a7f77ca-73e0-4162-e063-6294a90a1418SPL ID 4a7f77ca-73e0-4162-e063-6294a90a1418SPL set ID 0e5842f2-74f6-1f02-01bc-07578bd3b393RxCUI 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

N450268044715 followed by a unit qualifier and the quantity

Package 50268-0447-15. 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 50268-447

What is NDC 50268-447?
50268-447 is the product NDC for Isosorbide Dinitrate, Isosorbide dinitrate 5 mg/1 tablet, listed with the FDA by AvPAK. 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?
AvPAK, NDC labeler code 50268. 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 086923

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

FDA NDC Directory listings under ANDA 086923
ProductStrengthForm · routeLabelerProduct NDC
Isosorbide DinitrateIsosorbide dinitrate 5 mg/1TabletOralPar Health USA, LLC49884-020

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in