Drug company (FDA labeler)
Sunrise Pharmaceutical, Inc.
Name in FDA records: SUNRISE PHARMACEUTICAL, INC.
NDC labeler code: 11534
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 · 7 products
- Phentermine hydrochlorideLomaira · 4 products
- Benztropine mesylate3 products
- DiazepamValium, Valtoco · 3 products
- Hydroxyzine3 products
- DextroamphetamineZenzedi, Xelstrym, Dexedrine Spansule · 2 products
- SulfasalazineAzulfidine, Azulfidine En-Tabs · 2 products
- NaproxenNaprelan, Rugby All Day Relief · 2 products
- Folic acidQuiofic · 1 product
- Chlordiazepoxide hydrochloride and clidinium bromideLibrax · 1 product
- Sodium polystyrene sulfonateKionex · 1 product
- Butalbital, acetaminophen and caffeineFioricet · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| July 7, 2020 | ANDA211421 | Chlordiazepoxide hydrochloride and clidinium bromide CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE | Nuvo Pharms Inc |
| December 28, 2017 | ANDA209799 | Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | Nuvo Pharm |
| October 18, 2017 | ANDA210059 | Dextroamphetamine DEXTROAMPHETAMINE SULFATE | Nuvo Pharm |
| March 29, 2017 | ANDA207121 | Hydroxyzine HYDROXYZINE HYDROCHLORIDE | Nuvo Pharms Inc |
| October 28, 2016 | ANDA207118 | Butalbital, acetaminophen and caffeine BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Nuvo Pharms Inc |
| July 28, 2015 | ANDA204418 | Folic acid FOLIC ACID | Nuvo Pharms Inc |
| April 14, 2015 | ANDA204713 | Benztropine mesylate BENZTROPINE MESYLATE | Nuvo Pharm |
| December 5, 2014 | ANDA205019 | Phentermine hydrochloride PHENTERMINE HYDROCHLORIDE | Nuvo Pharm |
| November 28, 2014 | ANDA204071 | Sodium polystyrene sulfonate SODIUM POLYSTYRENE SULFONATE | Nuvo Pharms Inc |
| September 25, 2014 | ANDA205008 | Phentermine hydrochloride PHENTERMINE HYDROCHLORIDE | Nuvo Pharm |
| September 25, 2014 | ANDA205017 | Phentermine hydrochloride PHENTERMINE HYDROCHLORIDE | Nuvo Pharm |
| September 19, 2011 | ANDA091432 | Naproxen NAPROXEN | Nuvo Pharms Inc |
| January 11, 2002 | ANDA040349 | Sulfasalazine SULFASALAZINE | Nuvo Pharms Inc |
| January 11, 2002 | ANDA075339 | Sulfasalazine SULFASALAZINE | Nuvo Pharms Inc |
| February 25, 1986 | ANDA070464 | Diazepam DIAZEPAM | Nuvo Pharm |
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