SAPHRIS
- Product NDC
- 0052-0118
- 11-digit product format
- 000520118
- Labeler code
- 0052
- Product ID
- 0052-0118_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
- 5 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0052-0118-06 | 2022-04-06 | C162847 | 48780-1 | 9d75b9d0-b46a-f424-e053-dadaa90a57ce | 17209c32-56eb-4f84-954d-aed7b7a1b18d |
| 0052-0118-82 | 2022-04-06 | C162847 | 48780-1 | 9d75b9d0-b46a-f424-e053-dadaa90a57ce | 17209c32-56eb-4f84-954d-aed7b7a1b18d |
| 0052-0118-90 | 2022-04-06 | C162847 | 48780-1 | 9d75b9d0-b46a-f424-e053-dadaa90a57ce | 17209c32-56eb-4f84-954d-aed7b7a1b18d |
| 0052-0118-06 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-b46a-f424-e053-dadaa90a57ce | 17209c32-56eb-4f84-954d-aed7b7a1b18d |
| 0052-0118-82 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-b46a-f424-e053-dadaa90a57ce | 17209c32-56eb-4f84-954d-aed7b7a1b18d |
| 0052-0118-90 | 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 |
|---|---|---|---|---|---|
| 0052-0118-06 | EA - Each | 0052-0118 | 67b098b2-1f0c-4133-936c-15a4bc7068a7 | 1 | 2012-07-24 |
| 0052-0118-90 | EA - Each | 0052-0118 | fc7451a2-d88d-4a29-9486-f66bfb060c1d | 1 | 2012-07-24 |