Drug

Who makes nitrofurantoin (monohydrate/macrocrystals)?

21 companies list nitrofurantoin (monohydrate/macrocrystals) as a human prescription drug. Forms: capsule. Routes: oral.

Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology

Companies listing nitrofurantoin (monohydrate/macrocrystals)

CompanyFormsApplicationNDCsRegistered sites
NuCare Pharmaceuticals,Inc.United StatescapsuleANDAANDA077066, ANDA21735741
International Medication Systems, Ltd.United StatescapsuleANDAANDA077066, ANDA21101333
Bryant Ranch PrepackUnited StatescapsuleANDAANDA077066, ANDA209225, ANDA21735731
RemedyRepack, IncUnited StatescapsuleANDAANDA077066, ANDA21735731
ASCLEMED USA INC. DBA ENOVACHEMUnited StatescapsuleANDAANDA077066, ANDA21101321
Coupler LLCUnited StatescapsuleANDAANDA21735721
Northwind Health Company, LLCUnited StatescapsuleANDAANDA077066, ANDA21101321
PD-Rx Pharmaceuticals Inc.United StatescapsuleANDAANDA07706621
Proficient Rx LPUnited StatescapsuleANDAANDA077066, ANDA21735721
QPharma IncUnited StatescapsuleANDAANDA077066, ANDA21101321
RedPharm DrugUnited StatescapsuleANDAANDA211013, ANDA21735721
Sandoz Industrial Products S.AAustriacapsuleANDAANDA07706615
NCS HealthCare of KY, LLC dba Vangard LabsUnited StatescapsuleANDAANDA21101311
Preferred Pharmaceuticals Inc.United StatescapsuleANDAANDA21735711
St. Mary's Medical Park PharmacyUnited StatescapsuleANDAANDA07706611
BluePoint Laboratories Inc.capsuleANDAANDA21735710
Creekwood Pharmaceuticals LLCcapsuleANDAANDA22026910
Jubilant Cadista Pharmaceuticals Inc.capsuleANDAANDA21101310
Lifestar Pharma LLC.capsuleANDAANDA21735710
MAJOR Pharmaceuticals Inc.capsuleANDAANDA21735710
NorthStar RxLLCcapsuleANDAANDA21735710
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Common questions

Who makes nitrofurantoin (monohydrate/macrocrystals)?
21 companies list nitrofurantoin (monohydrate/macrocrystals) as a human prescription drug in the openFDA NDC Directory, led by NuCare Pharmaceuticals,Inc., International Medication Systems, Ltd., Bryant Ranch Prepack, RemedyRepack, Inc, ASCLEMED USA INC. DBA ENOVACHEM. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
Is there a generic nitrofurantoin (monohydrate/macrocrystals)?
21 companies list nitrofurantoin (monohydrate/macrocrystals) under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.