NDC codes

FDA NDC Directory
Product NDC (as listed)70518-3221Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-3221Add 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
70518-3221-270518322102705183221022 POUCH in 1 BOX (70518-3221-2) / 1 CAPSULE in 1 POUCH (70518-3221-3)Marketed from Nov 4, 2021
70518-3221-470518322104705183221042 CAPSULE in 1 BOTTLE, PLASTIC (70518-3221-4)Marketed from Mar 2, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Cefixime
Generic name (nonproprietary)
cefixime
Active ingredients
Cefixime — 400 mg/1
Dosage form
Capsule
Route
Oral
Labeler
REMEDYREPACK INC.NDC labeler code 70518
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 203195
Marketing start
Listing expires
Other FDA classes
Cephalosporins (Chemical structure)
Identifiers
Product ID 70518-3221_584f16e8-696b-ed5a-e063-6294a90a7ef0SPL ID 584f16e8-696b-ed5a-e063-6294a90a7ef0SPL set ID 3194433c-c04e-442b-9668-fbeb0a15bac7RxCUI 409823UNII 97I1C92E55
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

N470518322102 followed by a unit qualifier and the quantity

Package 70518-3221-02. 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)

Cefixime is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months and older with the following infections: Uncomplicated Urinary Tract Infections ( 1.1 ) Otitis Media ( 1.2 ) Pharyngitis and Tonsillitis ( 1.3 ) Acute Exacerbations of Chronic Bronchitis ( 1.4 ) Uncomplicated Gonorrhea (cervical/urethral) ( 1.5 ) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefixime and other antibacterial drugs, cefixime for oral suspension and cefixime capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70518-3221

What is NDC 70518-3221?
70518-3221 is the product NDC for Cefixime, Cefixime 400 mg/1 capsule, listed with the FDA by REMEDYREPACK INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cefixime.
What is the active ingredient?
Cefixime.
Who is the labeler?
REMEDYREPACK INC., NDC labeler code 70518. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cefixime?
10 other product NDCs are listed under this name. See all Cefixime 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 Cefixime NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
CefiximeCefixime 400 mg/1CapsuleOralREMEDYREPACK INC.70518-475970518-4759-00
CefiximeCefixime 400 mg/1CapsuleOralAurobindo Pharma Limited59651-64759651-0647-1059651-0647-50
CefiximeCefixime 400 mg/1TabletOralRising Pharma Holdings, Inc.64980-43064980-0430-01
CefiximeCefixime 400 mg/1CapsuleOralLupin Pharmaceuticals, Inc.68180-42368180-0423-0868180-0423-11
CefiximeCefixime 400 mg/1CapsuleOralREMEDYREPACK INC.70518-274970518-2749-0270518-2749-05
CefiximeCefixime 400 mg/1CapsuleOralAscend Laboratories, LLC67877-58467877-0584-0167877-0584-0567877-0584-33+1 more
CefiximeCefixime 100 mg/5mLPowder, For suspensionOralLupin Pharmaceuticals, Inc.68180-40568180-0405-01
CefiximeCefixime 200 mg/5mLPowder, For suspensionOralLupin Pharmaceuticals, Inc.68180-40768180-0407-0368180-0407-04
CefiximeCefixime 100 mg/5mLPowder, For suspensionOralAurobindo Pharma Limited65862-75165862-0751-0165862-0751-50
CefiximeCefixime 200 mg/5mLPowder, For suspensionOralAurobindo Pharma Limited65862-75265862-0752-5065862-0752-75

Other NDCs under NDA 203195

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

FDA NDC Directory listings under NDA 203195
ProductStrengthForm · routeLabelerProduct NDC
CefiximeCefixime 400 mg/1CapsuleOralLupin Pharmaceuticals, Inc.68180-423

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