Prescription drug · ANDA
Cefadroxil NDC 70518-3580
Cefadroxil 500 mg/1 · Capsule · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3580-0 | 7051835800070518358000 | 20 CAPSULE in 1 BLISTER PACK (70518-3580-0)Marketed from Nov 22, 2022 | |
| 70518-3580-1 | 7051835800170518358001 | 30 CAPSULE in 1 BLISTER PACK (70518-3580-1)Marketed from Dec 21, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065392
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 70518-3580_4f5b7578-a0ce-82db-e063-6394a90a8426SPL ID 4f5b7578-a0ce-82db-e063-6394a90a8426SPL set ID eb365f05-1c8f-4495-b443-abb0580b39fbRxCUI 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
N470518358000followed by a unit qualifier and the quantityPackage 70518-3580-00. 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 USP 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 monohydrate is generally effective in the eradication of streptococci from the oropharynx. Howe…
Excerpt only. Read the full label for complete information.
About NDC 70518-3580
- What is NDC 70518-3580?
- 70518-3580 is the product NDC for Cefadroxil, Cefadroxil 500 mg/1 capsule, listed with the FDA by REMEDYREPACK 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?
- REMEDYREPACK INC., NDC labeler code 70518. 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 | 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 |
| Cefadroxil | Cefadroxil 250 mg/5mL | Powder, For suspensionOral | NorthStar Rx LLC | 16714-389 | 16714-0389-01 |
Other NDCs under ANDA 065392
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 | PD-Rx Pharmaceuticals, Inc. | 43063-553 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Proficient Rx LP | 63187-883 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-9456 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Redpharm Drug | 67296-0491 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4690 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-180 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Preferred Pharmaceuticals, Inc. | 68788-8261 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Direct_Rx | 72189-445 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0432 |