Asenapine
- Product NDC
- 46708-199
- 11-digit product format
- 467080199
- Labeler code
- 46708
- Product ID
- 46708-199_b8b5c58b-40db-4b6f-b53d-f11a842bcf28
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Asenapine
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA206098
- Marketing category
- ANDA
- Marketing start
- 2020-12-10
- Substance
- ASENAPINE
- 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JKZ19V908O |
| Rxcui | 859975, 859981, 1606337 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-199-10 | Asenapine | 10 in 1 BLISTER PACK | TABLET | 10 | | 3 |
| 46708-199-31 | Asenapine | 100 in 1 CARTON | TABLET | 100 | | 3 |
| 46708-199-31 | Asenapine | 10 in 1 BLISTER PACK | TABLET | 10 | | 3 |
| 46708-199-60 | Asenapine | 60 in 1 CARTON | TABLET | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-199 | ASENAPINE TABLET [ALEMBIC PHARMACEUTICALS LIMITED] | 3 | Current NDC, Legacy NDC, 4 package rows | 20230121_cf587c48-9cd2-4dc5-b0e9-21783c5633a6.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 |
|---|
| 46708-199-10 | 46708019910 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 46708-199-31 | 46708019931 | 100 BLISTER PACK in 1 CARTON (46708-199-31) / 10 TABLET in 1 BLISTER PACK | 100 blister pack | 2020-12-10 | 0000-00-00 | No | No | Current |
| 46708-199-60 | 46708019960 | 60 BLISTER PACK in 1 CARTON (46708-199-60) / 10 TABLET in 1 BLISTER PACK (46708-199-10) | 60 blister pack | 2020-12-10 | 0000-00-00 | No | No | Current |