Asenapine
- Product NDC
- 51991-358
- 11-digit product format
- 519910358
- Labeler code
- 51991
- Product ID
- 51991-358_b48a6c73-5ff9-46da-ae10-6fc0ced6afc7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ASENAPINE MALEATE
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Breckenridge Pharmaceutical, Inc.
- Application
- ANDA205960
- Marketing category
- ANDA
- Marketing start
- 2021-03-08
- Substance
- ASENAPINE MALEATE
- Active strength
- 5 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 | 5 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 |
|---|
| 51991-358-11 | Asenapine | 10 in 1 BOX | TABLET | 10 | | 5 |
| 51991-358-60 | Asenapine | 6 in 1 BOX | TABLET | 6 | | 5 |
| 51991-358-60 | Asenapine | 10 in 1 BLISTER PACK | TABLET | 10 | | 5 |
| 51991-358-99 | Asenapine | 10 in 1 BLISTER PACK | TABLET | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51991-358 | ASENAPINE (ASENAPINE MALEATE) TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] | 5 | Current NDC, Legacy NDC, 4 package rows | 20240327_f5cd9abb-40e3-4cb5-a1b2-40cdba8a1c7e.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 |
|---|
| 51991-358-11 | 51991035811 | 10 BLISTER PACK in 1 BOX (51991-358-11) / 10 TABLET in 1 BLISTER PACK (51991-358-99) | 10 blister pack | 2021-03-08 | 0000-00-00 | No | No | Current |
| 51991-358-60 | 51991035860 | 6 BLISTER PACK in 1 BOX (51991-358-60) / 10 TABLET in 1 BLISTER PACK | 6 blister pack | 2021-03-08 | 0000-00-00 | No | No | Current |
| 51991-358-99 | 51991035899 | 10 in 1 BLISTER PACK | | | | | | Historical |