Prescription drug · ANDA
Cefaclor NDC 81948-6250
Cefaclor 250 mg/5mL · Suspension · Oral · Azorian Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81948-6250-1 | 8194862500181948625001 | 150 mL in 1 BOTTLE (81948-6250-1)Marketed from Nov 1, 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)
- Cefaclor
- Generic name (nonproprietary)
- cefaclor
- Active ingredients
- Cefaclor — 250 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Azorian Pharma, LLCNDC labeler code 81948
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065412
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 81948-6250_a6a7fcf7-b9dc-4dac-b127-418588586a8aSPL ID a6a7fcf7-b9dc-4dac-b127-418588586a8aSPL set ID 224af904-38f3-4210-a750-e21006db4c66RxCUI 313888UNII 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
N481948625001followed by a unit qualifier and the quantityPackage 81948-6250-01. 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 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 in…
Excerpt only. Read the full label for complete information.
About NDC 81948-6250
- What is NDC 81948-6250?
- 81948-6250 is the product NDC for Cefaclor, Cefaclor 250 mg/5mL suspension, listed with the FDA by Azorian Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cefaclor.
- What is the active ingredient?
- Cefaclor.
- Who is the labeler?
- Azorian Pharma, LLC, NDC labeler code 81948. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cefaclor?
- 4 other product NDCs are listed under this name. See all Cefaclor NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cefaclor products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cefaclor | Cefaclor 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1602 | 50090-1602-0050090-1602-02 |
| Cefaclor | Cefaclor 250 mg/1 | CapsuleOral | Carlsbad Technology, Inc. | 61442-171 | 61442-0171-0161442-0171-0561442-0171-30 |
| Cefaclor | Cefaclor 500 mg/1 | CapsuleOral | Carlsbad Technology, Inc. | 61442-172 | 61442-0172-0161442-0172-0561442-0172-30 |
| Cefaclor | Cefaclor 500 mg/1 | Tablet, Film coated, Extended releaseOral | Teva Pharmaceuticals USA, Inc. | 0093-1087 | 00093-1087-01 |