Prescription drug · ANDA

Cefdinir NDC 63187-835

Cefdinir 125 mg/5mL · Powder, For suspension · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)63187-835Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0835Add 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
63187-835-00631870835001 BOTTLE in 1 CARTON (63187-835-00) / 100 mL in 1 BOTTLEMarketed from May 1, 2017
63187-835-60631870835601 BOTTLE in 1 CARTON (63187-835-60) / 60 mL in 1 BOTTLEMarketed from May 1, 2017

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 — 125 mg/5mL
Dosage form
Powder, For suspension
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065473
Marketing start
Listing expires
Other FDA classes
Cephalosporins (Chemical structure)
Identifiers
Product ID 63187-835_5fcd955c-b46e-4949-b804-f81abe9d37b6SPL ID 5fcd955c-b46e-4949-b804-f81abe9d37b6SPL set ID be963e80-e298-49a0-a52f-3d4dcded7c8cRxCUI 309054UNII CI0FAO63WCUPC 0363187835002
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

N463187083500 followed by a unit qualifier and the quantity

Package 63187-0835-00. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 065473

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

FDA NDC Directory listings under ANDA 065473
ProductStrengthForm · routeLabelerProduct NDC
CefdinirCefdinir 250 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals,Inc.68071-5106
CefdinirCefdinir 250 mg/5mLPowder, For suspensionOralAurobindo Pharma Limited65862-219
CefdinirCefdinir 125 mg/5mLPowder, For suspensionOralAurobindo Pharma Limited65862-218
CefdinirCefdinir 125 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-6417
CefdinirCefdinir 250 mg/5mLPowder, For suspensionOralProficient Rx LP71205-405
CefdinirCefdinir 125 mg/5mLPowder, For suspensionOralDIRECT RX72189-185
CefdinirCefdinir 250 mg/5mLPowder, For suspensionOralDIRECT RX72189-186
CefdinirCefdinir 125 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals, Inc.68071-5318
CefdinirCefdinir 250 mg/5mLPowder, For suspensionOralPreferred Pharmaceuticals Inc.68788-7844
CefdinirCefdinir 125 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals,Inc.68071-4970
CefdinirCefdinir 250 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-2735

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