Prescription drug · NDA
Ella (ulipristal acetate) NDC 50090-5422
Ulipristal acetate 30 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-5422-0 | 50090542200 | 1 BLISTER PACK in 1 CARTON (50090-5422-0) / 1 TABLET in 1 BLISTER PACKMarketed from Jan 6, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Ella
- Generic name (nonproprietary)
- ulipristal acetate
- Active ingredients
- Ulipristal acetate — 30 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022474
- Marketing start
- Listing expires
- Other FDA classes
- Selective Progesterone Receptor Modulators (Mechanism)
- Identifiers
- Product ID 50090-5422_cb78d0c3-de38-40ed-a74b-8391b860e1cbSPL ID cb78d0c3-de38-40ed-a74b-8391b860e1cbSPL set ID e5f09468-7ac8-40ba-a85b-758a32f586c3RxCUI 1005924, 1005928UNII YF7V70N02B
- Pharmacologic class
- Progesterone Agonist/Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450090542200followed by a unit qualifier and the quantityPackage 50090-5422-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure [see Dosage and Administration (2.1) ] . E lla is not intended for routine use as a contraceptive. Ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. Ella is not intended for routine use as a contraceptive. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 022474
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ellaulipristal acetate | Ulipristal acetate 30 mg/1 | TabletOral | PMI Branded Pharmaceuticals, Inc. | 73302-456 |