What is NDC 67046-1687?

67046-1687 is the product NDC for Isosorbide Mononitrate, Isosorbide mononitrate 10 mg/1 tablet, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Coupler LLC, NDC labeler code 67046. 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 Mononitrate?

61 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Isosorbide Mononitrate NDC 67046-1687

NDC codes

FDA NDC Directory

Product NDC (as listed)67046-1687Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67046-1687Add 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
67046-1687-3	6704616870367046168703	30 TABLET in 1 BLISTER PACK (67046-1687-3)Marketed from Jul 6, 2026

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 Mononitrate
Generic name (nonproprietary): isosorbide mononitrate
Active ingredients: Isosorbide mononitrate — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Coupler LLCNDC labeler code 67046
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075147
Marketing start: Jul 6, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Nitrates (Chemical structure)Vasodilation (Physiologic effect)
Identifiers: Product ID 67046-1687_55f236a5-e62f-efbb-e063-6394a90a0d5bSPL ID 55f236a5-e62f-efbb-e063-6394a90a0d5bSPL set ID 55f240e1-3056-38cc-e063-6294a90a814eRxCUI 311192UNII LX1OH63030
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

N467046168703 followed by a unit qualifier and the quantity

Package 67046-1687-03. 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 Jul 6, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Isosorbide Mononitrate Tablets USP are indicated for the prevention and treatment of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate 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 67046-1687

What is NDC 67046-1687?: 67046-1687 is the product NDC for Isosorbide Mononitrate, Isosorbide mononitrate 10 mg/1 tablet, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Isosorbide Mononitrate.
What is the active ingredient?: Isosorbide mononitrate.
Who is the labeler?: Coupler LLC, NDC labeler code 67046. 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 Mononitrate?: 61 other product NDCs are listed under this name. See all Isosorbide Mononitrate 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 Mononitrate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Isosorbide Mononitrate	Isosorbide mononitrate 120 mg/1	Tablet, Extended releaseOral	AiPing Pharmaceutical, Inc.	11788-161	11788-0161-01
Isosorbide Mononitrate	Isosorbide mononitrate 30 mg/1	Tablet, Extended releaseOral	AiPing Pharmaceutical, Inc.	11788-159	11788-0159-0111788-0159-0511788-0159-10
Isosorbide Mononitrate	Isosorbide mononitrate 60 mg/1	Tablet, Extended releaseOral	AiPing Pharmaceutical, Inc.	11788-160	11788-0160-0111788-0160-0511788-0160-10
Isosorbide Mononitrate	Isosorbide mononitrate 20 mg/1	TabletOral	Genus Lifesciences Inc.	64950-251	64950-0251-01
Isosorbide Mononitrate	Isosorbide mononitrate 10 mg/1	TabletOral	Genus Lifesciences Inc.	64950-250	64950-0250-01
Isosorbide Mononitrate	Isosorbide mononitrate 10 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	62559-252	62559-0252-01
Isosorbide Mononitrate	Isosorbide mononitrate 20 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	62559-253	62559-0253-01
Isosorbide Mononitrate	Isosorbide mononitrate 60 mg/1	Tablet, Extended releaseOral	Coupler LLC	67046-1632	67046-1632-03
isosorbide mononitrate	Isosorbide mononitrate 20 mg/1	TabletOral	Coupler LLC	67046-1578	67046-1578-03
isosorbide mononitrate	Isosorbide mononitrate 10 mg/1	TabletOral	Coupler LLC	67046-1577	67046-1577-03

All 62 Isosorbide Mononitrate NDCs

Other NDCs under ANDA 075147

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

FDA NDC Directory listings under ANDA 075147
Product	Strength	Form · route	Labeler	Product NDC
Isosorbide Mononitrate	Isosorbide mononitrate 10 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	62559-252
Isosorbide Mononitrate	Isosorbide mononitrate 20 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	62559-253