ZEJULA
- Product NDC
- 69656-103
- 11-digit product format
- 696560103
- Labeler code
- 69656
- Product ID
- 69656-103_260fc974-c8bc-44c5-8f72-b2424254c10a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- niraparib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- GlaxoSmithKline LLC
- Application
- NDA208447
- Marketing category
- NDA
- Marketing start
- 2017-03-27
- Marketing end
- 0000-00-00
- Substance
- NIRAPARIB
- Active strength
- 100 mg/1
- Pharmacologic classes
- Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 69656-103 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 69656-103 | 69656-103-30 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 69656-103 | 69656-103-61 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| N208447-001 | ZEJULA | NIRAPARIB TOSYLATE | EQ 100MG BASE | CAPSULE / ORAL | | RLD | 2017-03-27 |
Orange Book patents#
Application-product, Patent, Expiration table| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|
| N208447-001 | 8071579 | 2027-08-12 | U-2655 | | 2019-11-22 |
| N208447-001 | 8143241 | 2027-08-12 | U-2655 | | 2019-11-22 |
| N208447-001 | 8436185 | 2029-04-24 | | Drug substance | 2017-04-24 |
| N208447-001 | 8071623 | 2031-03-27 | | Drug substance, Drug product | 2017-04-24 |
| N208447-001 | 8859562 | 2031-08-04 | U-2655 | | 2019-11-22 |
| N208447-001 | 11091459 | 2038-03-27 | | Drug product | 2021-09-07 |
| N208447-001 | 11673877 | 2038-03-27 | U-3646 | Drug product | 2023-07-11 |
| N208447-001 | 11673877 | 2038-03-27 | U-3647 | Drug product | 2023-07-11 |
Orange Book exclusivity#
Application-product, Exclusivity code, Expiration table| Application-product | Exclusivity code | Expiration |
|---|
| N208447-001 | ODE-277 | 2026-10-23 |
| N208447-001 | ODE-295 | 2027-04-29 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69656-103-30 | 69656010330 | 30 CAPSULE in 1 BOTTLE (69656-103-30) | 30 capsule | 2018-07-01 | 0000-00-00 | No | No | Current |
| 69656-103-61 | 69656010361 | 30 CAPSULE in 1 BOTTLE (69656-103-61) | 30 capsule | 2020-07-01 | 0000-00-00 | Yes | No | Current |
| 69656-103-90 | 69656010390 | 90 CAPSULE in 1 BOTTLE (69656-103-90) | 90 capsule | 2017-03-27 | 0000-00-00 | No | No | Current |