Prescription drug · ANDA
Cefaclor NDC 61442-171
Cefaclor 250 mg/1 · Capsule · Oral · Carlsbad Technology, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61442-171-01 | 6144201710161442017101 | 100 CAPSULE in 1 BOTTLE, PLASTIC (61442-171-01)Marketed from Jul 31, 2008 | |
| 61442-171-05 | 6144201710561442017105 | 500 CAPSULE in 1 BOTTLE, PLASTIC (61442-171-05)Marketed from Jul 31, 2008 | |
| 61442-171-30 | 6144201713061442017130 | 30 CAPSULE in 1 BOTTLE, PLASTIC (61442-171-30)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 — 250 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 61442-171_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
N461442017101followed by a unit qualifier and the quantityPackage 61442-0171-01. 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.
About NDC 61442-171
- What is NDC 61442-171?
- 61442-171 is the product NDC for Cefaclor, Cefaclor 250 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.
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 250 mg/5mL | SuspensionOral | Azorian Pharma, LLC | 81948-6250 | 81948-6250-01 |
| Cefaclor | Cefaclor 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1602 | 50090-1602-0050090-1602-02 |
| 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 |
Other NDCs under ANDA 065146
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 |
|---|---|---|---|---|
| Cefaclor | Cefaclor 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1602 |
| Cefaclor | Cefaclor 500 mg/1 | CapsuleOral | Carlsbad Technology, Inc. | 61442-172 |