NDC codes

FDA NDC Directory
Product NDC (as listed)43063-553Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43063-0553Add 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
43063-553-10430630553104306305531010 CAPSULE in 1 BOTTLE, PLASTIC (43063-553-10)Marketed from Sep 11, 2012
43063-553-14430630553144306305531414 CAPSULE in 1 BOTTLE, PLASTIC (43063-553-14)Marketed from Sep 11, 2012
43063-553-20430630553204306305532020 CAPSULE in 1 BOTTLE, PLASTIC (43063-553-20)Marketed from Sep 11, 2012
43063-553-28430630553284306305532828 CAPSULE in 1 BOTTLE, PLASTIC (43063-553-28)Marketed from Sep 11, 2012

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)
Cefadroxil
Generic name (nonproprietary)
cefadroxil
Active ingredients
Cefadroxil — 500 mg/1
Dosage form
Capsule
Route
Oral
Labeler
PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065392
Marketing start
Listing expires
Other FDA classes
Cephalosporins (Chemical structure)
Identifiers
Product ID 43063-553_2f3a95a9-25cd-d525-e063-6394a90a460fSPL ID 2f3a95a9-25cd-d525-e063-6394a90a460fSPL set ID f5bbbf87-f059-4bbd-aea9-27d31462654fRxCUI 309049UNII 280111G160UPC 0343063553145
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

N443063055310 followed by a unit qualifier and the quantity

Package 43063-0553-10. 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 Cefadroxil Capsules USP are indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases: Urinary tract infections caused by E. coli , P. mirabilis , and Klebsiella species. Skin and skin structure infections caused by staphylococci and/or streptococci. Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci). Note: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefadroxil monohydrate is generally effective in the eradication of streptococci from the oropharynx. Howe…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43063-553

What is NDC 43063-553?
43063-553 is the product NDC for Cefadroxil, Cefadroxil 500 mg/1 capsule, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cefadroxil.
What is the active ingredient?
Cefadroxil.
Who is the labeler?
PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cefadroxil?
39 other product NDCs are listed under this name. See all Cefadroxil 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 Cefadroxil NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
CefadroxilCefadroxil 500 mg/1CapsuleOralAdvanced Rx of Tennessee, LLC80425-043280425-0432-0180425-0432-0280425-0432-03
CefadroxilCefadroxil 500 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-040080425-0400-0180425-0400-0280425-0400-03
CefadroxilCefadroxil 500 mg/1CapsuleOralDirect_Rx72189-50672189-0506-0672189-0506-20
CefadroxilCefadroxil 500 mg/1CapsuleOralPreferred Pharmaceuticals Inc.68788-847968788-8479-0268788-8479-03
CefadroxilCefadroxil 500 mg/1CapsuleOralDirect_Rx72189-44572189-0445-0672189-0445-20
CefadroxilCefadroxil 500 mg/1CapsuleOralREMEDYREPACK INC.70518-358070518-3580-0070518-3580-01
CefadroxilCefadroxil 500 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-019880425-0198-0180425-0198-0280425-0198-03
CefadroxilCefadroxil 500 mg/1CapsuleOralPreferred Pharmaceuticals, Inc.68788-826168788-8261-0268788-8261-03
CefadroxilCefadroxil 500 mg/1CapsuleOralDIRECT RX72189-10372189-0103-0672189-0103-20
CefadroxilCefadroxil 500 mg/1CapsuleOralRedPharm Drug, Inc.67296-172767296-1727-0167296-1727-02

All 40 Cefadroxil NDCs

Other NDCs under ANDA 065392

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

FDA NDC Directory listings under ANDA 065392
ProductStrengthForm · routeLabelerProduct NDC
CefadroxilCefadroxil 500 mg/1CapsuleOralProficient Rx LP63187-883
CefadroxilCefadroxil 500 mg/1CapsuleOralBryant Ranch Prepack63629-9456
CefadroxilCefadroxil 500 mg/1CapsuleOralRedpharm Drug67296-0491
CefadroxilCefadroxil 500 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.68071-4690
CefadroxilCefadroxil 500 mg/1CapsuleOralLupin Pharmaceuticals, Inc.68180-180
CefadroxilCefadroxil 500 mg/1CapsuleOralPreferred Pharmaceuticals, Inc.68788-8261
CefadroxilCefadroxil 500 mg/1CapsuleOralREMEDYREPACK INC.70518-3580
CefadroxilCefadroxil 500 mg/1CapsuleOralDirect_Rx72189-445
CefadroxilCefadroxil 500 mg/1CapsuleOralAdvanced Rx of Tennessee, LLC80425-0432

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