Register entryShortage reported
- Registered sites
- 1
- Active NDC listings
- 4
- Live patents
- 0
- Shortage listings
- 2
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Analytical testing1Labelling1Finished drug manufacture1Packaging1Relabelling1Repackaging1sterilize1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Medefil, Inc. | 405 Windy Point Drive, Glendale Heights, Illinois (IL) 60139, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging, Relabelling, Repackaging, sterilize | 3001677091080738829 |
Alert
Drug shortage listings
2| Drug | Presentation | Status | Availability | Posted / updated |
|---|---|---|---|---|
| Atropine Sulfate InjectionAnesthesia, Neurology, Pediatric | Atropine Sulfate, Injection, 1 mg/10 mL (0.1 mg/mL) Syringes (NDC 64253-400-91) | Current | Available | 1 Jan 201215 Sept 2026 |
| Sterile Water InjectionOther | Sterile Water, Injection, 10 mL/10 mL (NDC 64253-020-30) | Current | Available | 23 Nov 202115 Sept 2026 |
Catalogue
Drug listings by form and route
44 active NDC listings: 4 human prescription drug. By marketing category: ANDA 3, NDA 1.
| Dosage form | NDCs |
|---|---|
| injection, solution | 4 |
| Route | NDCs |
|---|---|
| intravenous | 4 |
| intramuscular | 2 |
| subcutaneous | 2 |
| Labeller name on the listing | NDCs |
|---|---|
| medefil, inc. | 4 |
Catalogue
Marketed products
4| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Atropine Sulfate | Atropine Sulfate Injection | injection, solution, intravenous | 64253-400ANDA |
| Calcium Chloride | Calcium Chloride Injection | injection, solution, intravenous | 64253-900ANDA |
| Sterile Water | Sterile Water for Injection | injection, solution, intramuscular, intravenous, subcutaneous | 64253-020ANDA |
| sodium chloride | SODIUM CHLORIDE | injection, solution, intramuscular, intravenous, subcutaneous | 64253-202NDA |
Neighbours
Registered in the same town
1- Cardinal Health 418, Inc.Glendale Heights, IL
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Enquiry
Common questions
- Is Medefil, Inc. FDA approved?
- Medefil, Inc. holds 1 FDA-registered establishment 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 Medefil, Inc.'s drugs manufactured?
- The FDA register lists Glendale Heights, IL. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, relabelling, repackaging, sterilize.
- What drugs does Medefil, Inc. make?
- 4 products are listed under Medefil, Inc. in the openFDA NDC Directory, most often as injection, solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
- Are any Medefil, Inc. products in shortage?
- 2 presentations are currently listed in the FDA drug shortage database under Medefil, Inc., covering Atropine Sulfate Injection, Sterile Water Injection.
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.