What is NDC 49884-021?

49884-021 is the product NDC for Isosorbide Dinitrate, Isosorbide dinitrate 10 mg/1 tablet, listed with the FDA by Par Health USA, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Par Health USA, LLC, NDC labeler code 49884. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Isosorbide Dinitrate NDC 49884-021

NDC codes

FDA NDC Directory

Product NDC (as listed)49884-021Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49884-0021Add 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	Copy
49884-021-01	4988400210149884002101	100 TABLET in 1 BOTTLE (49884-021-01)Marketed from Dec 22, 1979
49884-021-10	4988400211049884002110	1000 TABLET in 1 BOTTLE (49884-021-10)Marketed from Dec 22, 1979

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 — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Par Health USA, LLCNDC labeler code 49884
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 086925
Marketing start: Dec 22, 1979
Listing expires: Dec 31, 2027
Other FDA classes: Nitrates (Chemical structure)Vasodilation (Physiologic effect)
Identifiers: Product ID 49884-021_90d3efd1-9d17-4bee-967d-30d2d7ba597cSPL ID 90d3efd1-9d17-4bee-967d-30d2d7ba597cSPL set ID 6df6a2fa-c56c-4eb6-a485-c16585420eb0RxCUI 197839, 206842, 314055, 381056UNII IA7306519NUPC 0349884009014, 0349884021016, 0349884020019, 0349884022013
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

N449884002101 followed by a unit qualifier and the quantity

Package 49884-0021-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

About NDC 49884-021

What is NDC 49884-021?: 49884-021 is the product NDC for Isosorbide Dinitrate, Isosorbide dinitrate 10 mg/1 tablet, listed with the FDA by Par Health USA, LLC. It has 2 package NDCs, 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?: Par Health USA, LLC, NDC labeler code 49884. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Isosorbide Dinitrate	Isosorbide dinitrate 10 mg/1	TabletOral	REMEDYREPACK INC.	70518-4405	70518-4405-00
Isosorbide dinitrate	Isosorbide dinitrate 30 mg/1	TabletOral	BluePoint Laboratories	68001-562	68001-0562-00
Isosorbide Dinitrate	Isosorbide dinitrate 10 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8463	00615-8463-39
Isosorbide Dinitrate	Isosorbide dinitrate 20 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8464	00615-8464-39
Isosorbide Dinitrate	Isosorbide dinitrate 30 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8465	00615-8465-39
Isosorbide Dinitrate	Isosorbide dinitrate 5 mg/1	TabletOral	Advagen Pharma Ltd	72888-081	72888-0081-0072888-0081-01
Isosorbide Dinitrate	Isosorbide dinitrate 10 mg/1	TabletOral	Advagen Pharma Ltd	72888-082	72888-0082-0072888-0082-01
Isosorbide Dinitrate	Isosorbide dinitrate 20 mg/1	TabletOral	Advagen Pharma Ltd	72888-083	72888-0083-0072888-0083-01
Isosorbide Dinitrate	Isosorbide dinitrate 30 mg/1	TabletOral	Advagen Pharma Ltd	72888-084	72888-0084-0072888-0084-01
Isosorbide Dinitrate	Isosorbide dinitrate 40 mg/1	TabletOral	Advagen Pharma Ltd	72888-085	72888-0085-0072888-0085-01

All 52 Isosorbide Dinitrate NDCs

Other NDCs under ANDA 086925

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

FDA NDC Directory listings under ANDA 086925
Product	Strength	Form · route	Labeler	Product NDC
Isosorbide Dinitrate	Isosorbide dinitrate 10 mg/1	TabletOral	AvPAK	50268-448
Isosorbide Dinitrate	Isosorbide dinitrate 10 mg/1	TabletOral	American Health Packaging	68084-082