NDC codes

FDA NDC Directory
Product NDC (as listed)0781-2176Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00781-2176Add 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
0781-2176-0100781217601100 CAPSULE in 1 BOTTLE (0781-2176-01)Marketed from Apr 6, 2007
0781-2176-600078121766060 CAPSULE in 1 BOTTLE (0781-2176-60)Marketed from Apr 6, 2007
0781-2176-64007812176643 CARTON in 1 CARTON (0781-2176-64) / 1 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACKMarketed from Apr 6, 2007
0781-2176-69007812176695 BLISTER PACK in 1 CARTON (0781-2176-69) / 10 CAPSULE in 1 BLISTER PACKMarketed from Apr 6, 2007

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Sandoz IncNDC labeler code 0781
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065330
Marketing start
Listing expires
Other FDA classes
Cephalosporins (Chemical structure)
Identifiers
Product ID 0781-2176_977d4566-20b3-4909-ad00-6cbea017798dSPL ID 977d4566-20b3-4909-ad00-6cbea017798dSPL set ID 38f6adf7-e26c-4764-8ec9-360813874dd4RxCUI 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

N400781217601 followed by a unit qualifier and the quantity

Package 00781-2176-01. 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 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 are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorgan…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0781-2176

What is NDC 0781-2176?
0781-2176 is the product NDC for Cefdinir, Cefdinir 300 mg/1 capsule, listed with the FDA by Sandoz Inc. It has 4 package NDCs, 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?
Sandoz Inc, NDC labeler code 0781. 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 065330

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

FDA NDC Directory listings under ANDA 065330
ProductStrengthForm · routeLabelerProduct NDC
CefdinirCefdinir 300 mg/1CapsuleOralProficient Rx LP63187-989

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