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Data / Drug companies / Ramelteon

Ramelteon: 29 companies and 41 products in the FDA NDC directory

Ramelteon is listed in the FDA National Drug Code Directory by 29 companies, with 41 products in commercial distribution. 40 of the products (97.6%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; tablet, and the newest product started marketing on July 27, 2026.

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Companies listing it
29
Products
41
Generic (ANDA) products
40 (97.6%)
Application numbers
11
Routes
Oral
Brand names
Rozerem
openFDA record search
api.fda.gov

Companies that list ramelteon

Ranked by number of products. Finished drugs in commercial distribution.

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Bryant Ranch Prepack5tablet, film coated; tabletGeneric drugs (ANDA)July 10, 2023
Bryant Ranch Prepack4tablet, film coated; tabletGeneric drugs (ANDA)April 21, 2026
Advanced Rx of Tennessee, LLC3tablet, film coated; tabletGeneric drugs (ANDA)July 27, 2026
Direct_Rx3tablet, film coated; tabletGeneric drugs (ANDA)June 1, 2023
Asclemed USA, Inc.2tablet, film coated; tabletGeneric drugs (ANDA)July 10, 2023
Actavis Pharma, Inc.1tabletGeneric drugs (ANDA)July 22, 2019
American Health Packaging1tabletGeneric drugs (ANDA)February 20, 2023
Asclemed USA Inc.1tabletGeneric drugs (ANDA)May 1, 2023
Aurobindo Pharma Limited1tablet, film coatedGeneric drugs (ANDA)July 10, 2023
AvKARE1tabletGeneric drugs (ANDA)December 21, 2020
AvPAK1tabletGeneric drugs (ANDA)May 20, 2026
Bryant Ranch Prepack1tabletGeneric drugs (ANDA)October 1, 2020
Golden State Medical Supply, Inc.1tablet, film coatedGeneric drugs (ANDA)November 25, 2022
Granules Pharmaceuticals Inc.1tabletGeneric drugs (ANDA)October 1, 2020
I3 Pharmaceuticals, LLC1tablet, film coatedGeneric drugs (ANDA)April 30, 2020
Kanchan Healthcare Inc1tablet, film coatedGeneric drugs (ANDA)April 21, 2026
Major Pharmaceuticals1tabletGeneric drugs (ANDA)January 10, 2025
Marlex Pharmaceuticals, Inc.1tablet, film coatedGeneric drugs (ANDA)July 1, 2026
Micro Labs Limited1tabletGeneric drugs (ANDA)May 1, 2023
Proficient Rx LP1tablet, film coatedGeneric drugs (ANDA)June 30, 2020
Proficient Rx LP1tabletGeneric drugs (ANDA)October 1, 2020
Remedyrepack Inc.1tablet, film coatedGeneric drugs (ANDA)January 20, 2025
Sportpharm LLC1tabletGeneric drugs (ANDA)May 1, 2023
Takeda Pharmaceuticals America, Inc.1tablet, film coatedNew drug applications (NDA)July 22, 2005
TruPharma, LLC1tablet, film coatedGeneric drugs (ANDA)June 30, 2020
Upsher-Smith Laboratories, LLC1tablet, film coatedGeneric drugs (ANDA)October 26, 2020
Xiromed, LLC1tablet, film coatedGeneric drugs (ANDA)November 25, 2022
Zydus Lifesciences Limited1tabletGeneric drugs (ANDA)July 23, 2019
Zydus Pharmaceuticals USA Inc.1tabletGeneric drugs (ANDA)July 23, 2019

Dosage forms

Dosage formProductsShare
Tablet, film coated2253.7%
Tablet1946.3%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)4097.6%
New drug applications (NDA)12.4%

Pharmacologic classes

Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.