NDC codes

FDA NDC Directory
Product NDC (as listed)68001-362Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68001-0362Add 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
68001-362-066800103620660 CAPSULE in 1 BOTTLE (68001-362-06)Marketed from Aug 1, 2018

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)
Cefdinir
Generic name (nonproprietary)
cefdinir
Active ingredients
Cefdinir — 300 mg/1
Dosage form
Capsule
Route
Oral
Labeler
BluePoint LaboratoriesNDC labeler code 68001
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065434
Marketing start
Listing expires
Other FDA classes
Cephalosporins (Chemical structure)
Identifiers
Product ID 68001-362_f80ad981-4642-03d3-e053-6394a90ab137SPL ID f80ad981-4642-03d3-e053-6394a90ab137SPL set ID e342b7cf-f527-476e-8119-b1fd81c58b55RxCUI 200346UNII CI0FAO63WC
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

N468001036206 followed by a unit qualifier and the quantity

Package 68001-0362-06. 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 cefdinir and other antibacterial drugs, cefdinir 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. Cefdinir capsules, USP are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated micro…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68001-362

What is NDC 68001-362?
68001-362 is the product NDC for Cefdinir, Cefdinir 300 mg/1 capsule, listed with the FDA by BluePoint Laboratories. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cefdinir.
What is the active ingredient?
Cefdinir.
Who is the labeler?
BluePoint Laboratories, NDC labeler code 68001. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cefdinir?
77 other product NDCs are listed under this name. See all Cefdinir 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 Cefdinir NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
CefdinirCefdinir 250 mg/5mLPowder, For suspensionOralPreferred Pharmaceuticals Inc.68788-410668788-4106-01
CefdinirCefdinir 300 mg/1CapsuleOralMajor Pharmaceuticals0904-756300904-7563-04
CefdinirCefdinir 300 mg/1CapsuleOralREMEDYREPACK INC.70518-416970518-4169-0070518-4169-0170518-4169-02+1 more
CefdinirCefdinir 300 mg/1CapsuleOralNorthwind Health Company, LLC82868-05982868-0059-20
CefdinirCefdinir 300 mg/1CapsuleOralAvKARE42291-04342291-0043-60
CefdinirCefdinir monohydrate 250 mg/5mLPowder, For suspensionOralPreferred Pharmaceuticals Inc.68788-865568788-8655-01
CefdinirCefdinir 300 mg/1CapsuleOralAmerican Health Packaging60687-69960687-0699-21
CefdinirCefdinir 300 mg/1CapsuleOralPreferred Pharmaceuticals Inc.68788-840468788-8404-02
CefdinirCefdinir 300 mg/1CapsuleOralDirect_Rx72189-42372189-0423-1472189-0423-20
CefdinirCefdinir 300 mg/1CapsuleOralPreferred Pharmaceuticals, Inc.68788-832368788-8323-02

All 78 Cefdinir NDCs

Other NDCs under ANDA 065434

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

FDA NDC Directory listings under ANDA 065434
ProductStrengthForm · routeLabelerProduct NDC
CefdinirCefdinir 300 mg/1CapsuleOralREMEDYREPACK INC.70518-1880
CefdinirCefdinir 300 mg/1CapsuleOralPreferred Pharmaceuticals Inc.68788-8404
CefdinirCefdinir 300 mg/1CapsuleOralA-S Medication Solutions50090-2719
CefdinirCefdinir 300 mg/1CapsuleOralAurobindo Pharma Limited65862-177
CefdinirCefdinir 300 mg/1CapsuleOralDirect_Rx72189-423
CefdinirCefdinir 300 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.68071-5145
CefdinirCefdinir 300 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.72789-550
CefdinirCefdinir 300 mg/1CapsuleOralPreferred Pharmaceuticals Inc.68788-7339
CefdinirCefdinir 300 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.43063-959
CefdinirCefdinir 300 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.72789-054
CefdinirCefdinir 300 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.43063-964
CefdinirCefdinir 300 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.72789-061
CefdinirCefdinir 300 mg/1CapsuleOralNuCare Pharmaceuticals, Inc.68071-3998
CefdinirCefdinir 300 mg/1CapsuleOralRising Pharma Holdings, Inc.57237-099
CefdinirCefdinir 300 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.68071-4007
CefdinirCefdinir 300 mg/1CapsuleOralProficient Rx LP71205-224
CefdinirCefdinir 300 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.68071-4946

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