Ella
- Product NDC
- 53002-2630
- 11-digit product format
- 530022630
- Labeler code
- 53002
- Product ID
- 53002-2630_28822df7-626a-43a0-8648-7ca0cc7b5c0a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ulipristal acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- NDA022474
- Marketing category
- NDA
- Marketing start
- 2020-05-11
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-2630-1 | Ella | 1 in 1 BLISTER PACK | TABLET | 1 | | 1 |
| 53002-2630-1 | Ella | 1 in 1 CARTON | TABLET | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-2630 | ELLA (ULIPRISTAL ACETATE) TABLET [RPK PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 2 package rows | 20220331_c775958f-9ea3-4a5c-9915-794d844e4024.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 |
|---|
| 53002-2630-1 | 53002263001 | 1 BLISTER PACK in 1 CARTON (53002-2630-1) > 1 TABLET in 1 BLISTER PACK | 1 blister pack | 2022-08-01 | 0000-00-00 | No | No | Current |