What is NDC 71610-788?

71610-788 is the product NDC for Isosorbide Mononitrate, Isosorbide mononitrate 30 mg/1 tablet, extended release, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 71610-788

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-788Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0788Add 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
71610-788-30	7161007883071610078830	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-788-30)Marketed from Feb 5, 2024
71610-788-60	7161007886071610078860	90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-788-60)Marketed from Feb 5, 2024

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 Mononitrate
Generic name (nonproprietary): isosorbide mononitrate
Active ingredients: Isosorbide mononitrate — 30 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210918
Marketing start: Nov 5, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Nitrates (Chemical structure)Vasodilation (Physiologic effect)
Identifiers: Product ID 71610-788_ed4b9b65-54be-40f0-b2d0-452b7d1b49c4SPL ID ed4b9b65-54be-40f0-b2d0-452b7d1b49c4SPL set ID 18cf36bc-e73f-4274-b381-c2f2aa02f57dRxCUI 317110UNII 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

N471610078830 followed by a unit qualifier and the quantity

Package 71610-0788-30. 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 6, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Isosorbide mononitrate extended-release tablets are indicated for the prevention 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 71610-788

What is NDC 71610-788?: 71610-788 is the product NDC for Isosorbide Mononitrate, Isosorbide mononitrate 30 mg/1 tablet, extended release, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 2 package NDCs, 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 10 mg/1	TabletOral	Coupler LLC	67046-1687	67046-1687-03
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

All 62 Isosorbide Mononitrate NDCs

Other NDCs under ANDA 210918

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

FDA NDC Directory listings under ANDA 210918
Product	Strength	Form · route	Labeler	Product NDC
Isosorbide Mononitrate	Isosorbide mononitrate 30 mg/1	Tablet, Extended releaseOral	A-S Medication Solutions	50090-5686
Isosorbide Mononitrate	Isosorbide mononitrate 30 mg/1	Tablet, Extended releaseOral	A-S Medication Solutions	50090-7038
Isosorbide Mononitrate	Isosorbide mononitrate 30 mg/1	Tablet, Extended releaseOral	Ingenus Pharmaceuticals, LLC	50742-175
Isosorbide Mononitrate	Isosorbide mononitrate 60 mg/1	Tablet, Extended releaseOral	Ingenus Pharmaceuticals, LLC	50742-176
Isosorbide Mononitrate	Isosorbide mononitrate 120 mg/1	Tablet, Extended releaseOral	Ingenus Pharmaceuticals, LLC	50742-177
Isosorbide Mononitrate	Isosorbide mononitrate 30 mg/1	Tablet, Extended releaseOral	Golden State Medical Supply, Inc.	51407-208
Isosorbide Mononitrate	Isosorbide mononitrate 60 mg/1	Tablet, Extended releaseOral	Golden State Medical Supply, Inc.	51407-209
Isosorbide Mononitrate	Isosorbide mononitrate 120 mg/1	Tablet, Extended releaseOral	Golden State Medical Supply, Inc.	51407-210
Isosorbide Mononitrate	Isosorbide mononitrate 30 mg/1	Tablet, Extended releaseOral	Northwind Health Company, LLC	51655-922
Isosorbide Mononitrate	Isosorbide mononitrate 60 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-2192
Isosorbide Mononitrate	Isosorbide mononitrate 30 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-2194
Isosorbide Mononitrate	Isosorbide mononitrate 60 mg/1	Tablet, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-772
Isosorbide Mononitrate	Isosorbide mononitrate 30 mg/1	Tablet, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-825