Prescription drug · ANDA

Isosorbide Mononitrate NDC 71335-2194

Isosorbide mononitrate 30 mg/1 · Tablet, Extended release · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2194Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2194Add 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
71335-2194-1713352194017133521940130 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2194-1)Marketed from Apr 3, 2024
71335-2194-2713352194027133521940290 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2194-2)Marketed from Sep 6, 2023
71335-2194-3713352194037133521940360 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2194-3)Marketed from Apr 11, 2023
71335-2194-47133521940471335219404120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2194-4)Marketed from Nov 18, 2022
71335-2194-5713352194057133521940510 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2194-5)Marketed from Apr 3, 2024
71335-2194-67133521940671335219406100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2194-6)Marketed from Apr 3, 2024

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 — 30 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210918
Marketing start
Listing expires
Other FDA classes
Nitrates (Chemical structure)Vasodilation (Physiologic effect)
Identifiers
Product ID 71335-2194_a862daa7-dcfb-4f6e-90db-b712a7829fe8SPL ID a862daa7-dcfb-4f6e-90db-b712a7829fe8SPL set ID 441ddd35-6cb8-44d0-8009-1635390ede83RxCUI 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

N471335219401 followed by a unit qualifier and the quantity

Package 71335-2194-01. 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 .

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 71335-2194

What is NDC 71335-2194?
71335-2194 is the product NDC for Isosorbide Mononitrate, Isosorbide mononitrate 30 mg/1 tablet, extended release, listed with the FDA by Bryant Ranch Prepack. It has 6 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Isosorbide MononitrateIsosorbide mononitrate 120 mg/1Tablet, Extended releaseOralAiPing Pharmaceutical, Inc.11788-16111788-0161-01
Isosorbide MononitrateIsosorbide mononitrate 30 mg/1Tablet, Extended releaseOralAiPing Pharmaceutical, Inc.11788-15911788-0159-0111788-0159-0511788-0159-10
Isosorbide MononitrateIsosorbide mononitrate 60 mg/1Tablet, Extended releaseOralAiPing Pharmaceutical, Inc.11788-16011788-0160-0111788-0160-0511788-0160-10
Isosorbide MononitrateIsosorbide mononitrate 10 mg/1TabletOralCoupler LLC67046-168767046-1687-03
Isosorbide MononitrateIsosorbide mononitrate 20 mg/1TabletOralGenus Lifesciences Inc.64950-25164950-0251-01
Isosorbide MononitrateIsosorbide mononitrate 10 mg/1TabletOralGenus Lifesciences Inc.64950-25064950-0250-01
Isosorbide MononitrateIsosorbide mononitrate 10 mg/1TabletOralANI Pharmaceuticals, Inc.62559-25262559-0252-01
Isosorbide MononitrateIsosorbide mononitrate 20 mg/1TabletOralANI Pharmaceuticals, Inc.62559-25362559-0253-01
Isosorbide MononitrateIsosorbide mononitrate 60 mg/1Tablet, Extended releaseOralCoupler LLC67046-163267046-1632-03
isosorbide mononitrateIsosorbide mononitrate 20 mg/1TabletOralCoupler LLC67046-157867046-1578-03

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
ProductStrengthForm · routeLabelerProduct NDC
Isosorbide MononitrateIsosorbide mononitrate 30 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-5686
Isosorbide MononitrateIsosorbide mononitrate 30 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-7038
Isosorbide MononitrateIsosorbide mononitrate 30 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-175
Isosorbide MononitrateIsosorbide mononitrate 60 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-176
Isosorbide MononitrateIsosorbide mononitrate 120 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-177
Isosorbide MononitrateIsosorbide mononitrate 30 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.51407-208
Isosorbide MononitrateIsosorbide mononitrate 60 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.51407-209
Isosorbide MononitrateIsosorbide mononitrate 120 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.51407-210
Isosorbide MononitrateIsosorbide mononitrate 30 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC51655-922
Isosorbide MononitrateIsosorbide mononitrate 60 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-2192
Isosorbide MononitrateIsosorbide mononitrate 60 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-772
Isosorbide MononitrateIsosorbide mononitrate 30 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-788
Isosorbide MononitrateIsosorbide mononitrate 30 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-825

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