Cefdinir
CEFDINIR CAPSULES, USP 300 mg Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
63aa0304-574f-4d37-9fb4-26ffb058fbec
HUMAN PRESCRIPTION DRUG LABEL
Aug 20, 2025
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cefdinir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (11)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Cefdinir 300mg Capsule#20 Alkem
DESCRIPTION SECTION
DESCRIPTION
Cefdinir capsules, USP contain the active ingredient cefdinir, an extended-
spectrum, semisynthetic cephalosporin, for oral administration. Chemically,
cefdinir is [6R-[6α,7β (Z)]]-7-[[(2-amino-4 thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-
carboxylic acid. Cefdinir is a white to slightly brownish-yellow solid. It is
slightly soluble in dilute hydrochloric acid and sparingly soluble in 0.1 M pH
7.0 phosphate buffer.The empirical formula is C14H13N5O5S2 and the molecular
weight is 395.42. Cefdinir has the structural formula shown below:
Cefdinir capsules, USP contain 300 mg cefdinir and the following inactive ingredients:
carboxymethylcellulose calcium, polyoxyl 40 stearate, colloidal silicone dioxide and magnesium stearate.
The capsule shells contain FD&C Blue #2; gelatin, titanium dioxide, gelatin and water. Imprinting ink components shellac, Black Iron Oxide and potassium hydroxide.
HOW SUPPLIED SECTION
HOW SUPPLIED
Cefdinir capsules, USP containing 300 mg cefdinir, having off white to light yellow colour granular powder filled in size “0” hard gelatin capsules, blue opaque cap imprinted “A041” with black ink and blue opaque body imprinted “300” with black ink.
NDC: 63629-8968-1: 20 CAPSULEs in a BOTTLE
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504