Ortho Cyclen
- Product NDC
- 50458-197
- 11-digit product format
- 504580197
- Labeler code
- 50458
- Product ID
- 50458-197_a5100f0c-d6a0-4340-91ab-04bb630476cb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- norgestimate and ethinyl estradiol
- Dosage form
- KIT
- Labeler
- Janssen Pharmaceuticals, Inc.
- Application
- NDA019653
- Marketing category
- NDA
- Marketing start
- 1989-12-29
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50458-197-00 | EA - Each | 50458-197 | 550d17c2-021d-4a53-b353-1d47c5b38901 | 1 | 2016-05-16 |
| 50458-197-06 | EA - Each | 50458-197 | 0728f84f-9f7a-468b-abc6-3d75cbee663b | 1 | 2018-05-09 |
| 50458-197-12 | EA - Each | 50458-197 | 40e02a33-2996-42d2-9109-f326ca6b55b1 | 1 | 2018-05-09 |
| 50458-197-15 | EA - Each | 50458-197 | e4a563a7-720b-49d7-a736-135aa81f99be | 1 | 2012-07-24 |
| 50458-197-28 | EA - Each | 50458-197 | fdbc49e4-1684-4977-ae18-dad57313eb8c | 1 | 2018-05-09 |