Asenapine
- Product NDC
- 69539-059
- 11-digit product format
- 695390059
- Labeler code
- 69539
- Product ID
- 69539-059_0c0d566e-5315-4e29-a207-5f2eb75910f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ASENAPINE MALEATE
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- MSN LABORATORIES PRIVATE LIMITED
- Application
- ANDA205960
- Marketing category
- ANDA
- Marketing start
- 2021-08-27
- Substance
- ASENAPINE MALEATE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Asenapine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ASENAPINE MALEATE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CU9463U2E2 |
| Rxcui | 859975, 859981, 1606337 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69539-059-34 | Asenapine | 60 in 1 BOX | TABLET | 60 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69539-059 | ASENAPINE (ASENAPINE MALEATE) TABLET [MSN LABORATORIES PRIVATE LIMITED] | 7 | Current NDC, Legacy NDC, 1 package rows | 20210902_4c7a1b17-e73e-4417-a172-bfb03569d7ff.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69539-059-34 | 69539005934 | 60 TABLET in 1 BOX (69539-059-34) | 60 tablet | 2021-08-27 | 0000-00-00 | No | No | Current |