NDC codes

FDA NDC Directory
Product NDC (as listed)81948-6250Labeler and product segments. Claims need a package NDC.
Product NDC at billing width81948-6250Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
81948-6250-18194862500181948625001150 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

N481948625001 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Cefaclor NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
CefaclorCefaclor 500 mg/1CapsuleOralA-S Medication Solutions50090-160250090-1602-0050090-1602-02
CefaclorCefaclor 250 mg/1CapsuleOralCarlsbad Technology, Inc.61442-17161442-0171-0161442-0171-0561442-0171-30
CefaclorCefaclor 500 mg/1CapsuleOralCarlsbad Technology, Inc.61442-17261442-0172-0161442-0172-0561442-0172-30
CefaclorCefaclor 500 mg/1Tablet, Film coated, Extended releaseOralTeva Pharmaceuticals USA, Inc.0093-108700093-1087-01

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