Prescription drug · ANDA
Cefadroxil NDC 65862-084
Cefadroxil 500 mg/5mL · Powder, For suspension · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-084-01 | 6586200840165862008401 | 100 mL in 1 BOTTLE (65862-084-01)Marketed from Apr 25, 2013 | |
| 65862-084-50 | 6586200845065862008450 | 50 mL in 1 BOTTLE (65862-084-50)Marketed from Apr 25, 2013 | |
| 65862-084-75 | 6586200847565862008475 | 75 mL in 1 BOTTLE (65862-084-75)Marketed from Apr 25, 2013 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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/5mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065349
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 65862-084_74923cbc-7511-447d-b6b2-b2d0e805a0f5SPL ID 74923cbc-7511-447d-b6b2-b2d0e805a0f5SPL set ID 776a8dbc-e68e-4732-acf4-0133dca0f54cRxCUI 105171, 309048UNII 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
N465862008401followed by a unit qualifier and the quantityPackage 65862-0084-01. 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 is 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 establishing the e…
Excerpt only. Read the full label for complete information.
About NDC 65862-084
- What is NDC 65862-084?
- 65862-084 is the product NDC for Cefadroxil, Cefadroxil 500 mg/5mL powder, for suspension, listed with the FDA by Aurobindo Pharma Limited. It has 3 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?
- Aurobindo Pharma Limited, NDC labeler code 65862. 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 065349
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 250 mg/5mL | Powder, For suspensionOral | NorthStar Rx LLC | 16714-389 |
| Cefadroxil | Cefadroxil 500 mg/5mL | Powder, For suspensionOral | NorthStar Rx LLC | 16714-390 |
| Cefadroxil | Cefadroxil 250 mg/5mL | Powder, For suspensionOral | Rising Pharma Holdings, Inc. | 57237-097 |
| Cefadroxil | Cefadroxil 500 mg/5mL | Powder, For suspensionOral | Rising Pharma Holdings, Inc. | 57237-098 |
| Cefadroxil | Cefadroxil 250 mg/5mL | Powder, For suspensionOral | Aurobindo Pharma Limited | 65862-083 |