What is NDC 0781-1635?

0781-1635 is the product NDC for Isosorbide Dinitrate, Isosorbide dinitrate 5 mg/1 tablet, listed with the FDA by Sandoz Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Sandoz Inc., NDC labeler code 0781. 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 0781-1635 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-1635Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-1635Add 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
0781-1635-01	00781163501	100 TABLET in 1 BOTTLE (0781-1635-01)Marketed from Jan 7, 1988
0781-1635-10	00781163510	1000 TABLET in 1 BOTTLE (0781-1635-10)Marketed from Jan 7, 1988

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Sandoz Inc.NDC labeler code 0781
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 086221
Marketing start: Jan 7, 1988
Listing expires: Dec 31, 2026
Other FDA classes: Nitrates (Chemical structure)Vasodilation (Physiologic effect)
Identifiers: Product ID 0781-1635_9c848a4f-2720-4c80-a0be-e49200cb10f9SPL ID 9c848a4f-2720-4c80-a0be-e49200cb10f9SPL set ID 71fdd147-a987-40b6-9f07-82d56525ceb8RxCUI 206842, 314055, 381056UNII IA7306519NUPC 0307811556017, 0307811695013, 0307811635019
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

N400781163501 followed by a unit qualifier and the quantity

Package 00781-1635-01. 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 Feb 1, 2024.

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 0781-1635

What is NDC 0781-1635?: 0781-1635 is the product NDC for Isosorbide Dinitrate, Isosorbide dinitrate 5 mg/1 tablet, listed with the FDA by Sandoz Inc.. 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?: Sandoz Inc., NDC labeler code 0781. 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	Advagen Pharma Ltd	72888-082	72888-0082-0072888-0082-01
Isosorbide Dinitrate	Isosorbide dinitrate 5 mg/1	TabletOral	Advagen Pharma Ltd	72888-081	72888-0081-0072888-0081-01
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
Isosorbide Dinitrate	Isosorbide dinitrate 20 mg/1	TabletOral	Proficient Rx LP	82804-108	82804-0108-3082804-0108-90
Isosorbide Dinitrate	Isosorbide dinitrate 10 mg/1	TabletOral	Proficient Rx LP	82804-117	82804-0117-90
Isosorbide Dinitrate	Isosorbide dinitrate 10 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8463	00615-8463-39

All 52 Isosorbide Dinitrate NDCs