NDC codes

FDA NDC Directory
Product NDC (as listed)0093-1087Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00093-1087Add 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
0093-1087-010009310870100093108701100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-1087-01)Marketed from Sep 26, 2002

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Tablet, Film coated, Extended release
Route
Oral
Labeler
Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065058
Marketing start
Listing expires
Other FDA classes
Cephalosporins (Chemical structure)
Identifiers
Product ID 0093-1087_61ec00e0-d37d-4aa4-8f50-031ee7a37eccSPL ID 61ec00e0-d37d-4aa4-8f50-031ee7a37eccSPL set ID 0878bdc2-0410-4938-9890-96523aa81c2fRxCUI 309043UNII 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

N400093108701 followed by a unit qualifier and the quantity

Package 00093-1087-01. 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 To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefaclor extended-release tablets USP and other antibacterial drugs, cefaclor extended-release tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The safety and effectiveness of cefaclor extended-release tablets in treating some of the indic…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0093-1087

What is NDC 0093-1087?
0093-1087 is the product NDC for Cefaclor, Cefaclor 500 mg/1 tablet, film coated, extended release, listed with the FDA by Teva Pharmaceuticals USA, Inc.. 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?
Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. 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/1CapsuleOralCarlsbad Technology, Inc.61442-17261442-0172-0161442-0172-0561442-0172-30

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