Register entryShortage reported
- Registered sites
- 1
- Active NDC listings
- 54
- Labeller names
- 3
- Live patents
- 0
- Shortage listings
- 14
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Labelling1Finished drug manufacture1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Elite Laboratories, Inc. | 165\144\135 Ludlow Avenue, Northvale, New Jersey (NJ) 07647, United States (USA) | Labelling, Finished drug manufacture | 3002644678785398728 |
Alert
Drug shortage listings
14| Drug | Presentation | Status | Availability | Posted / updated |
|---|---|---|---|---|
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletPsychiatry | Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 5 mg; 5 mg; 5 mg; 5 mg (NDC 64850-505-01) | Current | Available | 12 Oct 20222 Oct 2026 |
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletPsychiatry | Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 3.125 mg; 3.125 mg; 3.125 mg; 3.125 mg (NDC 64850-503-01) | Current | Available | 12 Oct 20222 Oct 2026 |
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletPsychiatry | Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg (NDC 64850-506-01) | Current | Available | 15 Aug 20232 Oct 2026 |
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletPsychiatry | Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg (NDC 64850-502-01) | Current | Available | 12 Oct 20222 Oct 2026 |
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletPsychiatry | Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 1.875 mg; 1.875 mg; 1.875 mg; 1.875 mg (NDC 64850-501-01) | Current | Available | 12 Oct 20222 Oct 2026 |
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletPsychiatry | Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg (NDC 64850-500-01) | Current | Available | 12 Oct 20222 Oct 2026 |
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletPsychiatry | Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg (NDC 64850-504-01) | Current | Available | 12 Oct 20222 Oct 2026 |
| Lisdexamfetamine Dimesylate CapsulePsychiatry | Lisdexamfetamine Dimesylate, Capsule, 40 mg (NDC 64850-553-01) | Current | Limited Availability | 14 Jul 20232 Oct 2026 |
| Lisdexamfetamine Dimesylate CapsulePsychiatry | Lisdexamfetamine Dimesylate, Capsule, 50 mg (NDC 64850-554-01) | Current | Limited Availability | 14 Jul 20232 Oct 2026 |
| Lisdexamfetamine Dimesylate CapsulePsychiatry | Lisdexamfetamine Dimesylate, Capsule, 60 mg (NDC 64850-555-01) | Current | Limited Availability | 14 Jul 20232 Oct 2026 |
| Lisdexamfetamine Dimesylate CapsulePsychiatry | Lisdexamfetamine Dimesylate, Capsule, 70 mg (NDC 64850-556-01) | Current | Limited Availability | 14 Jul 20232 Oct 2026 |
| Lisdexamfetamine Dimesylate CapsulePsychiatry | Lisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 64850-550-01) | Current | Limited Availability | 14 Jul 20232 Oct 2026 |
| Lisdexamfetamine Dimesylate CapsulePsychiatry | Lisdexamfetamine Dimesylate, Capsule, 30 mg (NDC 64850-552-01) | Current | Limited Availability | 14 Jul 20232 Oct 2026 |
| Lisdexamfetamine Dimesylate CapsulePsychiatry | Lisdexamfetamine Dimesylate, Capsule, 20 mg (NDC 64850-551-01) | Current | Limited Availability | 14 Jul 20232 Oct 2026 |
Catalogue
Drug listings by form and route
5454 active NDC listings: 53 human prescription drug, 1 human otc drug. By marketing category: ANDA 53, OTC MONOGRAPH DRUG 1.
| Dosage form | NDCs |
|---|---|
| tablet | 22 |
| capsule | 19 |
| capsule, extended release | 6 |
| tablet, extended release | 5 |
| cream | 1 |
| tablet, film coated | 1 |
| Route | NDCs |
|---|---|
| oral | 53 |
| topical | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| elite laboratories, inc. | 52 |
| elite laboratories, inc | 1 |
| pt elite products llc | 1 |
Catalogue
Marketed products
54| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Acetaminophen and Codeine Phosphate | Acetaminophen and Codeine Phosphate | tablet, oral | 64850-641ANDA |
| Acetaminophen and Codeine Phosphate | Acetaminophen and Codeine Phosphate | tablet, oral | 64850-642ANDA |
| Acetaminophen and Codeine Phosphate | Acetaminophen and Codeine Phosphate | tablet, oral | 64850-643ANDA |
| Dantrolene Sodium | dantrolene sodium | capsule, oral | 64850-840ANDA |
| Dantrolene Sodium | dantrolene sodium | capsule, oral | 64850-841ANDA |
| Dantrolene Sodium | dantrolene sodium | capsule, oral | 64850-842ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | capsule, extended release, oral | 64850-510ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | capsule, extended release, oral | 64850-511ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | capsule, extended release, oral | 64850-512ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | capsule, extended release, oral | 64850-513ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | capsule, extended release, oral | 64850-514ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | capsule, extended release, oral | 64850-515ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | tablet, oral | 64850-500ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | tablet, oral | 64850-501ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | tablet, oral | 64850-502ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | tablet, oral | 64850-503ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | tablet, oral | 64850-504ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | tablet, oral | 64850-505ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | tablet, oral | 64850-506ANDA |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | tablet, oral | 64850-630ANDA |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | tablet, oral | 64850-631ANDA |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | tablet, oral | 64850-632ANDA |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | tablet, oral | 64850-633ANDA |
| Isradipine | Isradipine | capsule, oral | 64850-910ANDA |
| Isradipine | Isradipine | capsule, oral | 64850-911ANDA |
| Lisdexamfetamine Dimesylate | lisdexamfetamine dimesylate | capsule, oral | 64850-550ANDA |
| Lisdexamfetamine Dimesylate | lisdexamfetamine dimesylate | capsule, oral | 64850-551ANDA |
| Lisdexamfetamine Dimesylate | lisdexamfetamine dimesylate | capsule, oral | 64850-552ANDA |
| Lisdexamfetamine Dimesylate | lisdexamfetamine dimesylate | capsule, oral | 64850-553ANDA |
| Lisdexamfetamine Dimesylate | lisdexamfetamine dimesylate | capsule, oral | 64850-554ANDA |
| Lisdexamfetamine Dimesylate | lisdexamfetamine dimesylate | capsule, oral | 64850-555ANDA |
| Lisdexamfetamine Dimesylate | lisdexamfetamine dimesylate | capsule, oral | 64850-556ANDA |
| Loxapine | Loxapine | capsule, oral | 64850-890ANDA |
| Loxapine | Loxapine | capsule, oral | 64850-891ANDA |
| Loxapine | Loxapine | capsule, oral | 64850-892ANDA |
| Loxapine | Loxapine | capsule, oral | 64850-893ANDA |
| Methadone Hydrochloride | Methadone Hydrochloride | tablet, oral | 64850-603ANDA |
| Methadone Hydrochloride | Methadone Hydrochloride | tablet, oral | 64850-604ANDA |
| Methotrexate Sodium | Methotrexate Sodium | tablet, oral | 64850-330ANDA |
| Naltrexone Hydrochloride | Naltrexone Hydrochloride | tablet, film coated, oral | 64850-300ANDA |
| Oxycodone Hydrochloride and Acetaminophen | Oxycodone Hydrochloride and Acetaminophen | tablet, oral | 64850-621ANDA |
| Oxycodone Hydrochloride and Acetaminophen | Oxycodone Hydrochloride and Acetaminophen | tablet, oral | 64850-622ANDA |
| Oxycodone Hydrochloride and Acetaminophen | Oxycodone Hydrochloride and Acetaminophen | tablet, oral | 64850-623ANDA |
| PHENDIMETRAZINE TARTRATE | Phendimetrazine Tartrate | tablet, oral | 64850-440ANDA |
| PT Elite Premium Pain Relief | CAPSAICIN, MENTHOL | cream, topical | 85808-615OTC MONOGRAPH DRUG |
| Phentermine Hydrochloride | Phentermine Hydrochloride | tablet, oral | 64850-810ANDA |
| Ropinirole | Ropinirole | tablet, extended release, oral | 64850-250ANDA |
| Ropinirole | Ropinirole | tablet, extended release, oral | 64850-251ANDA |
| Ropinirole | Ropinirole | tablet, extended release, oral | 64850-252ANDA |
| Ropinirole | Ropinirole | tablet, extended release, oral | 64850-253ANDA |
| Ropinirole | Ropinirole | tablet, extended release, oral | 64850-254ANDA |
| Trimipramine Maleate | Trimipramine Maleate | capsule, oral | 64850-850ANDA |
| Trimipramine Maleate | Trimipramine Maleate | capsule, oral | 64850-851ANDA |
| Trimipramine Maleate | Trimipramine Maleate | capsule, oral | 64850-852ANDA |
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Enquiry
Common questions
- Is Elite Laboratories, Inc. FDA approved?
- Elite Laboratories, 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 Elite Laboratories, Inc.'s drugs manufactured?
- The FDA register lists Northvale, NJ. Registered operations: labelling, finished drug manufacture.
- What drugs does Elite Laboratories, Inc. make?
- 54 products are listed under Elite Laboratories, Inc. in the openFDA NDC Directory, most often as tablet; capsule; capsule, extended release. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
- Are any Elite Laboratories, Inc. products in shortage?
- 14 presentations are currently listed in the FDA drug shortage database under Elite Laboratories, Inc., covering Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet, Lisdexamfetamine Dimesylate Capsule.
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.