Prescription drug · ANDA
Cefaclor NDC 50090-1602
Cefaclor 500 mg/1 · Capsule · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-1602-0 | 50090160200 | 30 CAPSULE in 1 BOTTLE (50090-1602-0)Marketed from Feb 20, 2019 | |
| 50090-1602-2 | 50090160202 | 21 CAPSULE in 1 BOTTLE (50090-1602-2)Marketed from Jan 6, 2015 |
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)
- Cefaclor
- Generic name (nonproprietary)
- cefaclor
- Active ingredients
- Cefaclor — 500 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065146
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 50090-1602_bdfc38c7-4047-429b-a6c1-1100fc4caaaaSPL ID bdfc38c7-4047-429b-a6c1-1100fc4caaaaSPL set ID d79a4b28-ef2b-4f0f-baec-002df7d06dd4RxCUI 197449UNII 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
N450090160200followed by a unit qualifier and the quantityPackage 50090-1602-00. 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 Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus pyogenes Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influ…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065146
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.