Register entryRepackager / relabeller
Assertio Specialty Pharmaceuticals, LLC
Data as of · How to read this entry
- Registered sites
- 3
- Active NDC listings
- 4
- Labeller names
- 3
- Live patents
- 0
- Shortage listings
- 7
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Labelling3
Sites
Registered establishments
3| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Assertio Specialty Pharmaceuticals, LLC | 100 S. Saunders Road Suite 300, Lake Forest, Illinois (IL) 60045, United States (USA) | Labelling | 3021594503118478447 |
| Assertio Therapeutics, Inc. | 100 S. Saunders Road, Suite 300, Lake Forest, Illinois (IL) 60045, United States (USA) | Labelling | 3003099171119510391 |
| Zyla Life Sciences US LLCRegistrant: Assertio Therapeutics, Inc. | 100 S. Saunders Road, Suite 300, Lake Forest, Illinois (IL) 60045, United States (USA) | Labelling | 3013684924079581441 |
Alert
Drug shortage listings
7| Drug | Presentation | Status | Availability | Posted / updated |
|---|---|---|---|---|
| Methotrexate InjectionRheumatology | Otrexup, Injection, 10 mg/.4 mL (NDC 82497-010-04) | To Be Discontinued | - | 29 Aug 202529 Aug 2025 |
| Methotrexate InjectionRheumatology | Otrexup, Injection, 22.5 mg/.4 mL (NDC 82497-022-04) | To Be Discontinued | - | 29 Aug 202529 Aug 2025 |
| Methotrexate InjectionRheumatology | Otrexup, Injection, 15 mg/.4 mL (NDC 82497-015-04) | To Be Discontinued | - | 29 Aug 202529 Aug 2025 |
| Methotrexate InjectionRheumatology | Otrexup, Injection, 20 mg/.4 mL (NDC 82497-020-04) | To Be Discontinued | - | 29 Aug 202529 Aug 2025 |
| Methotrexate InjectionRheumatology | Otrexup, Injection, 17.5 mg/.4 mL (NDC 82497-017-04) | To Be Discontinued | - | 29 Aug 202529 Aug 2025 |
| Methotrexate InjectionRheumatology | Otrexup, Injection, 25 mg/.4 mL (NDC 82497-025-04) | To Be Discontinued | - | 29 Aug 202529 Aug 2025 |
| Methotrexate InjectionRheumatology | Otrexup, Injection, 12.5 mg/.4 mL (NDC 82497-012-04) | To Be Discontinued | - | 29 Aug 202529 Aug 2025 |
Catalogue
Drug listings by form and route
44 active NDC listings: 4 human prescription drug. By marketing category: NDA 3, BLA 1.
| Dosage form | NDCs |
|---|---|
| capsule, liquid filled | 2 |
| injection, solution | 1 |
| powder, for solution | 1 |
| Route | NDCs |
|---|---|
| oral | 3 |
| subcutaneous | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| assertio therapeutics, inc. | 2 |
| assertio specialty pharmaceuticals llc | 1 |
| assertio specialty pharmaceuticals, llc | 1 |
Catalogue
Marketed products
4| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Cambia | diclofenac potassium | powder, for solution, oral | 13913-012NDA |
| Rolvedon | eflapegrastim-xnst | injection, solution, subcutaneous | 82497-132BLA |
| ZIPSOR | diclofenac potassium | capsule, liquid filled, oral | 13913-008NDA |
| ZIPSOR | diclofenac potassium | capsule, liquid filled, oral | 82497-008NDA |
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Enquiry
Common questions
- Is Assertio Specialty Pharmaceuticals, LLC FDA approved?
- Assertio Specialty Pharmaceuticals, LLC holds 3 FDA-registered establishments in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are Assertio Specialty Pharmaceuticals, LLC's registered sites?
- The FDA register lists Lake Forest, IL. Registered operations: labelling.
- What drugs does Assertio Specialty Pharmaceuticals, LLC make?
- 4 products are listed under Assertio Specialty Pharmaceuticals, LLC in the openFDA NDC Directory, most often as capsule, liquid filled; injection, solution; powder, for solution. 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.