Ella
- Product NDC
- 50102-911
- 11-digit product format
- 501020911
- Labeler code
- 50102
- Product ID
- 50102-911_d6ca82aa-9488-4aa7-a5f1-69873ecb8d0e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ulipristal acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Afaxys Pharma LLC
- Application
- NDA022474
- Marketing category
- NDA
- Marketing start
- 2010-08-13
- Marketing end
- 0000-00-00
- Substance
- ULIPRISTAL ACETATE
- Active strength
- 30 mg/1
- Pharmacologic classes
- Progesterone Agonist/Antagonist [EPC],Selective Progesterone Receptor Modulators [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 2e4780ec-bddd-4be9-81f2-6de14b4e7739 | Product name | 1 | 20170504 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50102-911-01 | 2023-02-16 | C162847 | 48780-1 | f386c649-df45-0266-e053-dadaa90a7c1a | 052bfe45-c485-49e5-8fc4-51990b2efba4 |
| 50102-911-01 | 2023-01-30 | C162847 | 48780-1 | f386c649-df45-0266-e053-dadaa90a7c1a | 052bfe45-c485-49e5-8fc4-51990b2efba4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50102-911-01 | EA - Each | 50102-911 | 827374c9-33ef-4d49-910f-c1d1c11f6213 | 1 | 2014-05-02 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1005928 | Ella 30 MG Oral Tablet | PSN | 4bc8f664-d3af-4ca5-8bbd-7d120da8027d | 12 |
| 1005924 | ulipristal acetate 30 MG Oral Tablet | PSN | 4bc8f664-d3af-4ca5-8bbd-7d120da8027d | 12 |
| 1005928 | ulipristal acetate 30 MG Oral Tablet [Ella] | SBD | 4bc8f664-d3af-4ca5-8bbd-7d120da8027d | 12 |
| 1005924 | ulipristal acetate 30 MG Oral Tablet | SCD | 4bc8f664-d3af-4ca5-8bbd-7d120da8027d | 12 |
| 1005928 | Ella 30 MG Oral Tablet | SY | 4bc8f664-d3af-4ca5-8bbd-7d120da8027d | 12 |
| 1005928 | Ella 30 MG Oral Tablet | PSN | 04bb31a9-1682-4941-a7cb-a6526d226776 | 5 |
| 1005924 | ulipristal acetate 30 MG Oral Tablet | PSN | 04bb31a9-1682-4941-a7cb-a6526d226776 | 5 |
| 1005928 | ulipristal acetate 30 MG Oral Tablet [Ella] | SBD | 04bb31a9-1682-4941-a7cb-a6526d226776 | 5 |
| 1005924 | ulipristal acetate 30 MG Oral Tablet | SCD | 04bb31a9-1682-4941-a7cb-a6526d226776 | 5 |
| 1005928 | Ella 30 MG Oral Tablet | SY | 04bb31a9-1682-4941-a7cb-a6526d226776 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50102-911-01 | 50102091101 | 1 BLISTER PACK in 1 CARTON (50102-911-01) > 1 TABLET in 1 BLISTER PACK | 1 blister pack | 2010-08-13 | 0000-00-00 | No | No | Current |