NDC codes

FDA NDC Directory
Product NDC (as listed)65862-068Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65862-0068Add 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
65862-068-016586200680165862006801100 TABLET, FILM COATED in 1 BOTTLE (65862-068-01)Marketed from May 24, 2007
65862-068-056586200680565862006805500 TABLET, FILM COATED in 1 BOTTLE (65862-068-05)Marketed from May 24, 2007
65862-068-30658620068306586200683030 TABLET, FILM COATED in 1 BOTTLE (65862-068-30)Marketed from May 24, 2007
65862-068-50658620068506586200685050 TABLET, FILM COATED in 1 BOTTLE (65862-068-50)Marketed from May 24, 2007

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)
Cefprozil
Generic name (nonproprietary)
cefprozil
Active ingredients
Cefprozil — 250 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Aurobindo Pharma LimitedNDC labeler code 65862
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065340
Marketing start
Listing expires
Identifiers
Product ID 65862-068_6397ff45-3c37-40c3-a924-d036bb896b3bSPL ID 6397ff45-3c37-40c3-a924-d036bb896b3bSPL set ID b9111a81-07c4-4458-b994-a4ad504986d8RxCUI 197452, 197453UNII 4W0459ZA4VUPC 0365862069016

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

N465862006801 followed by a unit qualifier and the quantity

Package 65862-0068-01. 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 cefprozil and other antibacterial drugs, cefprozil 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. Cefprozil tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorg…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65862-068

What is NDC 65862-068?
65862-068 is the product NDC for Cefprozil, Cefprozil 250 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cefprozil.
What is the active ingredient?
Cefprozil.
Who is the labeler?
Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cefprozil?
21 other product NDCs are listed under this name. See all Cefprozil 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 Cefprozil NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
CefprozilCefprozil 250 mg/5mLPowder, For suspensionOralLupin Pharmaceuticals, Inc.68180-27368180-0273-0168180-0273-0268180-0273-03
CefprozilCefprozil 500 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-24367877-0243-50
CefprozilCefprozil 250 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-24467877-0244-01
CefprozilCefprozil 250 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-39816714-0398-01
CefprozilCefprozil 500 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-39916714-0399-01
CefprozilCefprozil 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-171050090-1710-00
CefprozilCefprozil 250 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.57237-03657237-0036-01
CefprozilCefprozil 500 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.57237-03757237-0037-0157237-0037-50
CefprozilCefprozil 125 mg/5mLPowder, For suspensionOralNorthStar Rx LLC16714-39616714-0396-03
CefprozilCefprozil 250 mg/5mLPowder, For suspensionOralNorthStar Rx LLC16714-39716714-0397-0116714-0397-0216714-0397-03

All 22 Cefprozil NDCs

Other NDCs under ANDA 065340

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

FDA NDC Directory listings under ANDA 065340
ProductStrengthForm · routeLabelerProduct NDC
CefprozilCefprozil 250 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-398
CefprozilCefprozil 500 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-399
CefprozilCefprozil 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-1710
CefprozilCefprozil 250 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.57237-036
CefprozilCefprozil 500 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.57237-037

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in