NDC codes

FDA NDC Directory
Product NDC (as listed)50090-3226Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-3226Add 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
50090-3226-05009032260050 mL in 1 BOTTLE (50090-3226-0)Marketed from Oct 30, 2017

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)
Cefprozil
Generic name (nonproprietary)
cefprozil
Active ingredients
Cefprozil — 250 mg/5mL
Dosage form
Powder, For suspension
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065381
Marketing start
Listing expires
Identifiers
Product ID 50090-3226_3c117298-9cc5-4ebd-a581-82168ca396aeSPL ID 3c117298-9cc5-4ebd-a581-82168ca396aeSPL set ID 8e292a8d-9fd6-45fb-8fb5-d8cb25a4b46dRxCUI 309081UNII 4W0459ZA4V

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

N450090322600 followed by a unit qualifier and the quantity

Package 50090-3226-00. 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 065381

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

FDA NDC Directory listings under ANDA 065381
ProductStrengthForm · routeLabelerProduct NDC
CefprozilCefprozil 125 mg/5mLPowder, For suspensionOralAurobindo Pharma Limited65862-099
CefprozilCefprozil 250 mg/5mLPowder, For suspensionOralAurobindo Pharma Limited65862-100
CefprozilCefprozil 250 mg/5mLPowder, For suspensionOralRising Pharma Holdings, Inc.57237-035
CefprozilCefprozil 125 mg/5mLPowder, For suspensionOralRising Pharma Holdings, Inc.57237-034
CefprozilCefprozil 125 mg/5mLPowder, For suspensionOralNorthStar Rx LLC16714-396
CefprozilCefprozil 250 mg/5mLPowder, For suspensionOralNorthStar Rx LLC16714-397

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