NDC codes

FDA NDC Directory
Product NDC (as listed)61442-172Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61442-0172Add 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
61442-172-016144201720161442017201100 CAPSULE in 1 BOTTLE, PLASTIC (61442-172-01)Marketed from Jul 31, 2008
61442-172-056144201720561442017205500 CAPSULE in 1 BOTTLE, PLASTIC (61442-172-05)Marketed from Jul 31, 2008
61442-172-30614420172306144201723030 CAPSULE in 1 BOTTLE, PLASTIC (61442-172-30)Marketed from Jul 31, 2008

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)
Cefaclor
Generic name (nonproprietary)
cefaclor
Active ingredients
Cefaclor — 500 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Carlsbad Technology, Inc.NDC labeler code 61442
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 61442-172_3417e20b-604b-3cdd-e063-6394a90ac707SPL ID 3417e20b-604b-3cdd-e063-6394a90ac707SPL set ID 2f61354e-bcb0-41aa-955f-51eabc11387bRxCUI 197449, 309045UNII 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

N461442017201 followed by a unit qualifier and the quantity

Package 61442-0172-01. 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 influ…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61442-172

What is NDC 61442-172?
61442-172 is the product NDC for Cefaclor, Cefaclor 500 mg/1 capsule, listed with the FDA by Carlsbad Technology, Inc.. It has 3 package NDCs, 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?
Carlsbad Technology, Inc., NDC labeler code 61442. 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 250 mg/5mLSuspensionOralAzorian Pharma, LLC81948-625081948-6250-01
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/1Tablet, Film coated, Extended releaseOralTeva Pharmaceuticals USA, Inc.0093-108700093-1087-01

Other NDCs under ANDA 065146

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 065146
ProductStrengthForm · routeLabelerProduct NDC
CefaclorCefaclor 500 mg/1CapsuleOralA-S Medication Solutions50090-1602
CefaclorCefaclor 250 mg/1CapsuleOralCarlsbad Technology, Inc.61442-171

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