Novitium Pharma LLC
NDC labeler code: 70954
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
- Estazolam2 products
- Trihexyphenidyl hydrochloride2 products
- Bisoprolol fumarate2 products
- ClotrimazoleClotic (Clotrimazole) Otic Solution · 1 product
- LidocaineXylocaine Mpf, Xylocaine, Lidocaine Viscous · 1 product
- FelbamateFelbatol · 1 product
- Trimethoprim1 product
- Fludrocortisone acetate1 product
- Dicyclomine hydrochloride1 product
- Tranylcypromine sulfateParnate · 1 product
- Pyridostigmine bromideMestinon, Pryidostigmine Bromide, Regonol · 1 product
- Chlorzoxazone1 product
- Phenoxybenzamine hydrochloride1 product
- SelegilineEmsam, Zelapar · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| October 28, 2022 | ANDA216393 | Trimethoprim TRIMETHOPRIM | Novitium Pharma |
| July 19, 2022 | ANDA215042 | Phenoxybenzamine hydrochloride PHENOXYBENZAMINE HYDROCHLORIDE | Novitium Pharma |
| May 31, 2022 | ANDA215279 | Fludrocortisone acetate FLUDROCORTISONE ACETATE | Novitium Pharma |
| March 23, 2022 | ANDA216250 | Lidocaine LIDOCAINE HYDROCHLORIDE | Novitium Pharma |
| October 29, 2021 | ANDA215563 | Bisoprolol fumarate BISOPROLOL FUMARATE | Novitium Pharma |
| April 23, 2021 | ANDA214721 | Dicyclomine hydrochloride DICYCLOMINE HYDROCHLORIDE | Novitium Pharma |
| September 12, 2019 | ANDA212254 | Chlorzoxazone CHLORZOXAZONE | Novitium Pharma |
| May 31, 2019 | ANDA211333 | Felbamate FELBAMATE | Novitium Pharma |
| March 8, 2019 | ANDA211694 | Pyridostigmine bromide PYRIDOSTIGMINE BROMIDE | Novitium Pharma |
| February 15, 2019 | ANDA209815 | Clotrimazole CLOTRIMAZOLE | Novitium Pharma |
| April 17, 2018 | ANDA206856 | Tranylcypromine sulfate TRANYLCYPROMINE SULFATE | Novitium Pharma |
| December 24, 1998 | ANDA040254 | Trihexyphenidyl hydrochloride TRIHEXYPHENIDYL HYDROCHLORIDE | Novitium Pharma |
| November 30, 1998 | ANDA075352 | Selegiline SELEGILINE HYDROCHLORIDE | Novitium Pharma |
| July 3, 1997 | ANDA074826 | Estazolam ESTAZOLAM | Novitium Pharma |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2026
-
June 2, 2026 · Class III · Ongoing · D-0619-2026 · Hydroxyzine
Presence of foreign substance
hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10
-
May 12, 2026 · Class II · Ongoing · D-0543-2026 · Estradiol
Defective Container; packets were found to be either empty or partially full.
Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20
2024
-
March 25, 2024 · Class III · Terminated · D-0443-2024 · Digoxin
Failed Impurities/Degradation Specifications
Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-200-10
-
March 4, 2024 · Class III · Terminated · D-0389-2024 · Digoxin
Cross Contamination with Other Products:(mycophenolate mofetil).
Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-201-20
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
- All drug companiesA to Z
- 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