Register entry
- Registered sites
- 0
- Active NDC listings
- 5
- Labeller names
- 2
- Live patents
- 20
- Countries
- 0
Catalogue
Drug listings by form and route
55 active NDC listings: 5 human prescription drug. By marketing category: NDA 4, ANDA 1.
| Dosage form | NDCs |
|---|---|
| tablet | 2 |
| spray, metered | 1 |
| suppository | 1 |
| suspension | 1 |
| Route | NDCs |
|---|---|
| oral | 3 |
| nasal | 1 |
| rectal | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| zyla life sciences us llc | 4 |
| zyla life sciences us inc. | 1 |
Exclusivity
Patents and exclusivities
20| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 8679544 | ZORVOLEXdiclofenac | product | Apr 2030 |
| 8999387 | ZORVOLEXdiclofenac | use | Apr 2030 |
| 9017721 | ZORVOLEXdiclofenac | product | Apr 2030 |
| 9173854 | ZORVOLEXdiclofenac | product | Apr 2030 |
| 9180095 | ZORVOLEXdiclofenac | use | Apr 2030 |
| 9180096 | ZORVOLEXdiclofenac | product | Apr 2030 |
| 9186328 | ZORVOLEXdiclofenac | use | Apr 2030 |
| 9044402 | ARYMO ERmorphine sulfate | product | Jul 2033 |
| 9549899 | ARYMO ERmorphine sulfate | product | Jul 2033 |
Catalogue
Marketed products
5| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| INDOCIN | Indomethacin | suppository, rectal | 69344-102ANDA |
| Indocin | indomethacin | suspension, oral | 69344-101NDA |
| OXAYDO | OXYCODONE HYDROCHLORIDE | tablet, oral | 69344-113NDA |
| OXAYDO | OXYCODONE HYDROCHLORIDE | tablet, oral | 69344-213NDA |
| Sprix | ketorolac tromethamine | spray, metered, nasal | 69344-144NDA |
Compare
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- NuCare Pharmaceuticals,Inc.1 site · 1,393 NDC
- Direct Rx1 site · 554 NDC
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- St. Mary's Medical Park Pharmacy1 site · 273 NDC
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Enquiry
Common questions
- Is Zyla Life Sciences US Inc. FDA approved?
- Zyla Life Sciences US Inc. holds no registered establishment of its own; 5 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
- What drugs does Zyla Life Sciences US Inc. make?
- 5 products are listed under Zyla Life Sciences US Inc. in the openFDA NDC Directory, most often as tablet; spray, metered; suppository. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.