Prescription drug · ANDA
Cefaclor NDC 0093-1087
Cefaclor 500 mg/1 · Tablet, Film coated, Extended release · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-1087-01 | 00093108701 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-1087-01)Marketed from Sep 26, 2002 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Cefaclor
- Generic name (nonproprietary)
- cefaclor
- Active ingredients
- Cefaclor — 500 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065058
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 0093-1087_61ec00e0-d37d-4aa4-8f50-031ee7a37eccSPL ID 61ec00e0-d37d-4aa4-8f50-031ee7a37eccSPL set ID 0878bdc2-0410-4938-9890-96523aa81c2fRxCUI 309043UNII 69K7K19H4L
- Pharmacologic class
- Cephalosporin Antibacterial
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400093108701followed by a unit qualifier and the quantityPackage 00093-1087-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefaclor extended-release tablets USP and other antibacterial drugs, cefaclor extended-release tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The safety and effectiveness of cefaclor extended-release tablets in treating some of the indic…
Excerpt only. Read the full label for complete information.