Prescription drug · ANDA
Cefadroxil NDC 0093-3196
Cefadroxil 500 mg/1 · Capsule · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-3196-01 | 0009331960100093319601 | 100 CAPSULE in 1 BOTTLE (0093-3196-01)Marketed from Jan 31, 2007 | |
| 0093-3196-53 | 0009331965300093319653 | 50 CAPSULE in 1 BOTTLE (0093-3196-53)Marketed from Jan 31, 2007 |
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)
- Cefadroxil
- Generic name (nonproprietary)
- cefadroxil
- Active ingredients
- Cefadroxil — 500 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065282
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 0093-3196_86b8951f-3699-4888-9eeb-7bbda995ec35SPL ID 86b8951f-3699-4888-9eeb-7bbda995ec35SPL set ID bda86975-8c2f-4c4e-9a4c-a1a959f9336aRxCUI 309049UNII 280111G160
- 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
N400093319601followed by a unit qualifier and the quantityPackage 00093-3196-01. 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 Cefadroxil capsules are indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases: Urinary tract infections caused by E. coli , P. mirabilis , and Klebsiella species. Skin and skin structure infections caused by staphylococci and/or streptococci. Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci). Note: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefadroxil is generally effective in the eradication of streptococci from the oropharynx. However, data establ…
Excerpt only. Read the full label for complete information.
About NDC 0093-3196
- What is NDC 0093-3196?
- 0093-3196 is the product NDC for Cefadroxil, Cefadroxil 500 mg/1 capsule, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cefadroxil.
- What is the active ingredient?
- Cefadroxil.
- Who is the labeler?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cefadroxil?
- 39 other product NDCs are listed under this name. See all Cefadroxil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cefadroxil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0432 | 80425-0432-0180425-0432-0280425-0432-03 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0400 | 80425-0400-0180425-0400-0280425-0400-03 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Direct_Rx | 72189-506 | 72189-0506-0672189-0506-20 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8479 | 68788-8479-0268788-8479-03 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Direct_Rx | 72189-445 | 72189-0445-0672189-0445-20 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3580 | 70518-3580-0070518-3580-01 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0198 | 80425-0198-0180425-0198-0280425-0198-03 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Preferred Pharmaceuticals, Inc. | 68788-8261 | 68788-8261-0268788-8261-03 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | DIRECT RX | 72189-103 | 72189-0103-0672189-0103-20 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | RedPharm Drug, Inc. | 67296-1727 | 67296-1727-0167296-1727-02 |
Other NDCs under ANDA 065282
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Redpharm Drug | 67296-2199 |