NDC codes

FDA NDC Directory
Product NDC (as listed)43547-386Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43547-0386Add 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
43547-386-094354703860990 TABLET in 1 BOTTLE (43547-386-09)Marketed from Oct 1, 2017
43547-386-11435470386111000 TABLET in 1 BOTTLE (43547-386-11)Marketed from Oct 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)
Fosinopril sodium
Generic name (nonproprietary)
fosinopirl sodium
Active ingredients
Fosinopril sodium — 10 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205670
Marketing start
Listing expires
Other FDA classes
Angiotensin-converting Enzyme Inhibitors (Mechanism)
Identifiers
Product ID 43547-386_e39b61db-42b8-4ddf-89d1-549c08d49e71SPL ID e39b61db-42b8-4ddf-89d1-549c08d49e71SPL set ID 0a66f606-5e6f-473d-8a1e-9ef316adb2e2RxCUI 857169, 857183, 857187UNII NW2RTH6T2NUPC 0343547387099

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

N443547038609 followed by a unit qualifier and the quantity

Package 43547-0386-09. 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 205670

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

FDA NDC Directory listings under ANDA 205670
ProductStrengthForm · routeLabelerProduct NDC
Fosinopril sodiumFosinopril sodium 40 mg/1TabletOralA-S Medication Solutions50090-4743
Fosinopril sodiumfosinopirl sodiumFosinopril sodium 10 mg/1TabletOralBryant Ranch Prepack71335-0726
Fosinopril sodiumFosinopril sodium 40 mg/1TabletOralBryant Ranch Prepack71335-9703
Fosinopril sodiumFosinopril sodium 20 mg/1TabletOralSolco Healthcare LLC43547-387
Fosinopril sodiumFosinopril sodium 40 mg/1TabletOralSolco Healthcare LLC43547-388

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