Drug company (FDA labeler)
Elite Laboratories, Inc.
NDC labeler code: 64850
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
- Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfateAdderall, Mixed Salts of a Single Entity Amphetamine Product XR, Adderall XR · 13 products
- Lisdexamfetamine dimesylateVyvanse, Arynta · 7 products
- Ropinirole5 products
- Hydrocodone bitartrate and acetaminophenNorco · 4 products
- LoxapineAdasuve · 4 products
- Dantrolene sodiumRevonto, Dantrium, Ryanodex Dantrolene Sodium · 3 products
- Oxycodone and acetaminophenEndocet, Prolate, Percocet · 3 products
- Acetaminophen and codeine phosphate3 products
- Trimipramine maleate3 products
- Methadone hydrochlorideMethadone Hydrocloride Dye-Free, Sugar-Free, Unflavored, Methadose, Methadose Sugar-Free · 2 products
- Isradipine2 products
- Phendimetrazine tartrate1 product
- Naltrexone hydrochloride1 product
- MethotrexateRasuvo, Otrexup, Trexall · 1 product
- Phentermine hydrochlorideLomaira · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| November 10, 2025 | ANDA217862 | Ropinirole ROPINIROLE HYDROCHLORIDE | Elite Labs Inc |
| November 15, 2024 | ANDA218604 | Lisdexamfetamine dimesylate LISDEXAMFETAMINE DIMESYLATE | Elite Labs Inc |
| May 16, 2024 | ANDA216453 | Methotrexate METHOTREXATE SODIUM | Elite Labs Inc |
| December 11, 2019 | ANDA212037 | Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | Elite Labs Inc |
| September 10, 2019 | ANDA212418 | Acetaminophen and codeine phosphate ACETAMINOPHEN AND CODEINE PHOSPHATE | Elite Labs Inc |
| December 7, 2018 | ANDA211352 | Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | Elite Labs Inc |
| November 16, 2018 | ANDA209924 | Hydrocodone bitartrate and acetaminophen HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Elite Labs Inc |
| August 2, 2018 | ANDA210484 | Methadone hydrochloride METHADONE HYDROCHLORIDE | Elite Labs Inc |
| July 2, 2018 | ANDA209385 | Oxycodone and acetaminophen OXYCODONE AND ACETAMINOPHEN | Elite Labs Inc |
| January 28, 2008 | ANDA040762 | Phendimetrazine tartrate PHENDIMETRAZINE TARTRATE | Elite Labs Inc |
| August 2, 2006 | ANDA077361 | Trimipramine maleate TRIMIPRAMINE MALEATE | Elite Labs Inc |
| April 24, 2006 | ANDA077169 | Isradipine ISRADIPINE | Elite Labs Inc |
| October 24, 2005 | ANDA076686 | Dantrolene sodium DANTROLENE SODIUM | Elite Labs Inc |
| August 4, 2005 | ANDA076868 | Loxapine LOXAPINE SUCCINATE | Elite Labs Inc |
| May 26, 1999 | ANDA075274 | Naltrexone hydrochloride NALTREXONE HYDROCHLORIDE | Elite Labs |
| May 30, 1997 | ANDA040190 | Phentermine hydrochloride PHENTERMINE HYDROCHLORIDE | Elite Labs Inc |
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.
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