NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8655Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8655Add 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
68788-8655-168788865501100 mL in 1 BOTTLE (68788-8655-1)Marketed from May 9, 2024

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)
Cefdinir
Generic name (nonproprietary)
cefdinir
Active ingredients
Cefdinir monohydrate — 250 mg/5mL
Dosage form
Powder, For suspension
Route
Oral
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065332
Marketing start
Listing expires
Other FDA classes
Cephalosporins (Chemical structure)
Identifiers
Product ID 68788-8655_a1224216-2592-4f61-b9b5-6406cf43c0ebSPL ID a1224216-2592-4f61-b9b5-6406cf43c0ebSPL set ID 0d1212c9-604f-4999-8f7d-e7cf300705efRxCUI 476576UNII 6E7SN358SE
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

N468788865501 followed by a unit qualifier and the quantity

Package 68788-8655-01. 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 cefdinir for oral suspension, USP and other antibacterial drugs, cefdinir for oral suspension, 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. Cefdinir for oral suspension, USP is indicated for the treatment of patients with mild to moderate infe…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-8655

What is NDC 68788-8655?
68788-8655 is the product NDC for Cefdinir, Cefdinir monohydrate 250 mg/5mL powder, for suspension, listed with the FDA by Preferred Pharmaceuticals Inc.. 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 monohydrate.
Who is the labeler?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 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
CefdinirCefdinir 300 mg/1CapsuleOralDirectRx72189-30872189-0308-1472189-0308-20

All 78 Cefdinir NDCs

Other NDCs under ANDA 065332

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

FDA NDC Directory listings under ANDA 065332
ProductStrengthForm · routeLabelerProduct NDC
CefdinirCefdinir monohydrate 250 mg/5mLPowder, For suspensionOralProficient Rx LP63187-616
CefdinirCefdinir 125 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-4258
CefdinirCefdinir monohydrate 125 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals, Inc.68071-3156
CefdinirCefdinir monohydrate 250 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-3725
CefdinirCefdinir monohydrate 125 mg/5mLPowder, For suspensionOralTeva Pharmaceuticals USA, Inc.0093-4136
CefdinirCefdinir monohydrate 250 mg/5mLPowder, For suspensionOralTeva Pharmaceuticals USA, Inc.0093-4137

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