Isosorbide Mononitrate
- Product NDC
- 71610-772
- 11-digit product format
- 716100772
- Labeler code
- 71610
- Product ID
- 71610-772_10f2e7b3-b561-443d-9bfd-6c3420a9edb7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide Mononitrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA210918
- Marketing category
- ANDA
- Marketing start
- 2018-11-05
- Substance
- ISOSORBIDE MONONITRATE
- Active strength
- 60 mg/1
- Pharmacologic classes
- Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Isosorbide Mononitrate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ISOSORBIDE MONONITRATE | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | LX1OH63030 |
| Rxcui | 353538 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-772-30 | Isosorbide Mononitrate | 30 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 30 | | 2 |
| 71610-772-45 | Isosorbide Mononitrate | 45 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 45 | | 2 |
| 71610-772-60 | Isosorbide Mononitrate | 90 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 90 | | 2 |
| 71610-772-80 | Isosorbide Mononitrate | 180 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 180 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-772 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Current NDC, 4 package rows | 20240209_0af6c67f-919d-4515-8074-f6c3aaa835b5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-772-30 | 71610077230 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-772-30) | 2024-01-22 | No | No | Historical |
| 71610-772-45 | 71610077245 | 45 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-772-45) | 2024-01-22 | No | No | Historical |
| 71610-772-60 | 71610077260 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-772-60) | 2024-01-25 | No | No | Historical |
| 71610-772-80 | 71610077280 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-772-80) | 2024-01-22 | No | No | Historical |