Drug company (FDA labeler)
International Medication Systems, Limited
NDC labeler code: 76329
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- LidocaineXylocaine Mpf, Xylocaine, Lidocaine Viscous · 6 products
- Naloxone hydrochlorideNarcan, Rextovy, Zimhi · 3 products
- Iron sucroseVenofer · 3 products
- EpinephrineAuvi-Q, Adrenalin, Adrenalin (Epinephrine in Sodium Chloride) · 2 products
- Morphine sulfateMs Contin, Mitigo, Duramorph · 1 product
- Regadenoson (regadenoson anhydrous)1 product
- PhytonadioneVitamin K1 · 1 product
- Dextrose monohydrateInfant Dextrose · 1 product
- Sodium bicarbonate1 product
- Procainamide hydrochloride1 product
- LorazepamAtivan, Loreev XR · 1 product
- AtropineAtropen Auto-Injector, Isopto Atropine · 1 product
- Calcium chloride1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| August 8, 2025 | ANDA208977 | Iron sucrose IRON SUCROSE | Intl Medication Sys |
| August 15, 2022 | NDA211363 | Epinephrine EPINEPHRINE | Intl Medication Sys |
| May 23, 2022 | ANDA214252 | Regadenoson (regadenoson anhydrous) REGADENOSON | Ims Ltd |
| April 29, 2021 | ANDA202861 | Morphine sulfate MORPHINE SULFATE | Intl Medication Sys |
| March 26, 2021 | ANDA203451 | Dextrose monohydrate DEXTROSE 50% | Intl Medication Sys |
| October 5, 2020 | ANDA212461 | Atropine ATROPINE SULFATE | Intl Medication Sys |
| April 24, 2020 | ANDA211880 | Epinephrine EPINEPHRINE | Intl Medication Sys |
| May 9, 2018 | ANDA203477 | Calcium chloride CALCIUM CHLORIDE 10% | Intl Medication Sys |
| September 19, 2017 | ANDA203449 | Sodium bicarbonate SODIUM BICARBONATE | Intl Medication Sys |
| November 15, 2004 | ANDA076150 | Lorazepam LORAZEPAM | Intl Medication Sys |
| March 24, 1988 | ANDA072076 | Naloxone hydrochloride NALOXONE HYDROCHLORIDE | Intl Medication |
| July 31, 1984 | ANDA088636 | Procainamide hydrochloride PROCAINAMIDE HYDROCHLORIDE | Intl Medication |
| March 6, 1980 | ANDA086364 | Lidocaine LARYNG-O-JET KIT | Intl Medication |
| August 7, 1979 | ANDA086283 | Lidocaine LIDOCAINE HYDROCHLORIDE | Intl Medication |
| March 1, 1976 | ANDA083722 | Phytonadione PHYTONADIONE | Intl Medication |
| September 17, 1975 | ANDA083173 | Lidocaine LIDOCAINE HYDROCHLORIDE | Intl Medication |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
No recall of these products (by NDC code) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026