SAPHRIS
- Product NDC
- 0052-0119
- 11-digit product format
- 000520119
- Labeler code
- 0052
- Product ID
- 0052-0119_da55e2fe-c473-46cc-a4b4-d31c8e63d148
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Asenapine Maleate
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Organon Pharmaceuticals USA
- Application
- NDA022117
- Marketing category
- NDA
- Marketing start
- 2009-08-13
- Marketing end
- 0000-00-00
- Substance
- ASENAPINE MALEATE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5230498f-5ba0-2e92-5ec3-564c02237e72 | Product name | 3 | 20210607 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| e1a56ed3-15d0-4970-9174-95c3bde43653 | Product name | 1 | 20200309 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0052-0119-06 | 2022-04-06 | C162847 | 48780-1 | 9d75b9d0-b46a-f424-e053-dadaa90a57ce | 17209c32-56eb-4f84-954d-aed7b7a1b18d |
| 0052-0119-82 | 2022-04-06 | C162847 | 48780-1 | 9d75b9d0-b46a-f424-e053-dadaa90a57ce | 17209c32-56eb-4f84-954d-aed7b7a1b18d |
| 0052-0119-90 | 2022-04-06 | C162847 | 48780-1 | 9d75b9d0-b46a-f424-e053-dadaa90a57ce | 17209c32-56eb-4f84-954d-aed7b7a1b18d |
| 0052-0119-06 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-b46a-f424-e053-dadaa90a57ce | 17209c32-56eb-4f84-954d-aed7b7a1b18d |
| 0052-0119-82 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-b46a-f424-e053-dadaa90a57ce | 17209c32-56eb-4f84-954d-aed7b7a1b18d |
| 0052-0119-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-b46a-f424-e053-dadaa90a57ce | 17209c32-56eb-4f84-954d-aed7b7a1b18d |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0052-0119-06 | EA - Each | 0052-0119 | a226c4eb-aa6e-409c-a582-b1d7790a88ce | 1 | 2012-07-24 |
| 0052-0119-90 | EA - Each | 0052-0119 | 3d0bcffe-a0cb-4818-99da-359c51394bf8 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ASENAPINE MALEATE | ACTIVE INGREDIENT | CU9463U2E2 | SAPHRIS (ASENAPINE MALEATE) TABLET [STAT RX USA LLC] | 1 | |
| ASENAPINE | ACTIVE MOIETY | JKZ19V908O | SAPHRIS (ASENAPINE MALEATE) TABLET [STAT RX USA LLC] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | SAPHRIS (ASENAPINE MALEATE) TABLET [STAT RX USA LLC] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | SAPHRIS (ASENAPINE MALEATE) TABLET [STAT RX USA LLC] | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 859975 | asenapine 10 MG Sublingual Tablet | PSN | 03c696e9-0e6b-4e5c-be0a-41416f8019be | 1 |
| 859979 | Saphris 10 MG Sublingual Tablet | PSN | 03c696e9-0e6b-4e5c-be0a-41416f8019be | 1 |
| 859979 | asenapine 10 MG Sublingual Tablet [Saphris] | SBD | 03c696e9-0e6b-4e5c-be0a-41416f8019be | 1 |
| 859975 | asenapine 10 MG Sublingual Tablet | SCD | 03c696e9-0e6b-4e5c-be0a-41416f8019be | 1 |
| 859975 | asenapine (as asenapine maleate) 10 MG Sublingual Tablet | SY | 03c696e9-0e6b-4e5c-be0a-41416f8019be | 1 |
| 859979 | Saphris 10 MG Sublingual Tablet | SY | 03c696e9-0e6b-4e5c-be0a-41416f8019be | 1 |