Nordic Pharma, Inc.
NDC labeler code: 69918
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
- Desmopressin acetateDdavp, Stimate, Desmoda · 7 products
- Isoproterenol hydrochloride4 products
- LamotrigineLamictal, Lamictal XR, Subvenite · 4 products
- Neomycin sulfate, polymyxin b sulfate and dexamethasoneNeomycin and Polymyxin B Sulfates and Dexamethasone, Neomycin Polymyxin B Sulfates and Dexamethasone, Maxitrol · 1 product
- Tranexamic acidCyklokapron · 1 product
- Arsenic trioxideTrisenox · 1 product
- TimololTimoptic in Ocudose, Timoptic-Xe, Timoptic · 1 product
- SuccinylcholineAnectine, Quelicin · 1 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 |
|---|---|---|---|
| February 7, 2022 | ANDA216003 | Succinylcholine SUCCINYLCHOLINE CHLORIDE | Be Pharms |
| February 3, 2022 | ANDA214124 | Lamotrigine LAMOTRIGINE | J Molner |
| December 13, 2021 | ANDA212592 | Timolol TIMOLOL MALEATE | J Molner |
| May 19, 2021 | ANDA211237 | Isoproterenol hydrochloride ISOPROTERENOL HYDROCHLORIDE | J Molner |
| November 13, 2018 | ANDA210802 | Arsenic trioxide ARSENIC TRIOXIDE | J Molner |
| November 13, 2009 | NDA022430 | Tranexamic acid LYSTEDA | J Molner |
| September 6, 1995 | NDA019955 | Desmopressin acetate DDAVP | Ferring Pharms Inc |
| March 30, 1984 | NDA018938 | Desmopressin acetate DDAVP | J Molner |
| June 6, 1963 | NDA050023 | Neomycin sulfate, polymyxin b sulfate and dexamethasone MAXITROL | Harrow Eye |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2023
-
June 12, 2023 · Class III · Terminated · D-0871-2023 · Tranexamic acid
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312, NDC 69918-301-30
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
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- All prescription drugs A to ZSearch by generic, brand or Spanish name
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