Isosorbide Mononitrate
- Product NDC
- 42677-305
- 11-digit product format
- 426770305
- Labeler code
- 42677
- Product ID
- 42677-305_47b286d2-bbaf-75ff-e063-6294a90a6de7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide Mononitrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Shandong New Time Pharmaceutical Co., Ltd.
- Application
- ANDA214115
- Marketing category
- ANDA
- Marketing start
- 2024-02-08
- Substance
- ISOSORBIDE MONONITRATE
- Active strength
- 30 mg/1
- Pharmacologic classes
- Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Isosorbide Mononitrate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ISOSORBIDE MONONITRATE | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | LX1OH63030 |
| Rxcui | 311196, 317110, 353538 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42677-305-01 | Isosorbide Mononitrate | 60 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 60 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42677-305 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [SHANDONG NEW TIME PHARMACEUTICAL CO., LTD.] | 13 | Current NDC, 1 package rows | 20250509_cd953cfa-b6f5-4b82-afcc-52a57236b9d3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42677-305-01 | 42677030501 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42677-305-01) | 2024-02-08 | No | No | Current |