What is NDC 43547-388?

43547-388 is the product NDC for Fosinopril sodium, Fosinopril sodium 40 mg/1 tablet, listed with the FDA by Solco Healthcare LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Solco Healthcare LLC, NDC labeler code 43547. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Fosinopril sodium?

17 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fosinopril sodium NDC 43547-388 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43547-388Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43547-0388Add 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 NDC	11-digit (billing)	Package	Copy
43547-388-09	4354703880943547038809	90 TABLET in 1 BOTTLE (43547-388-09)Marketed from Oct 1, 2017
43547-388-11	4354703881143547038811	1000 TABLET in 1 BOTTLE (43547-388-11)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): fosinopril sodium
Active ingredients: Fosinopril sodium — 40 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Solco Healthcare LLCNDC labeler code 43547
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205670
Marketing start: Oct 1, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Angiotensin-converting Enzyme Inhibitors (Mechanism)
Identifiers: Product ID 43547-388_e39b61db-42b8-4ddf-89d1-549c08d49e71SPL ID e39b61db-42b8-4ddf-89d1-549c08d49e71SPL set ID 0a66f606-5e6f-473d-8a1e-9ef316adb2e2RxCUI 857169, 857183, 857187UNII NW2RTH6T2NUPC 0343547387099
Pharmacologic class: Angiotensin Converting Enzyme Inhibitor

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

N443547038809 followed by a unit qualifier and the quantity

Package 43547-0388-09. 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

Current FDA label (SPL), effective Oct 25, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Fosinopril sodium tablets are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION ). In using fosinopril sodium, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium does not have a simila…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43547-388

What is NDC 43547-388?: 43547-388 is the product NDC for Fosinopril sodium, Fosinopril sodium 40 mg/1 tablet, listed with the FDA by Solco Healthcare LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Fosinopril sodium.
What is the active ingredient?: Fosinopril sodium.
Who is the labeler?: Solco Healthcare LLC, NDC labeler code 43547. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fosinopril sodium?: 17 other product NDCs are listed under this name. See all Fosinopril sodium 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 Fosinopril sodium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Fosinopril sodiumfosinopirl sodium	Fosinopril sodium 10 mg/1	TabletOral	Solco Healthcare LLC	43547-386	43547-0386-0943547-0386-11
Fosinopril sodium	Fosinopril sodium 20 mg/1	TabletOral	Solco Healthcare LLC	43547-387	43547-0387-0943547-0387-11
Fosinopril sodium	Fosinopril sodium 40 mg/1	TabletOral	A-S Medication Solutions	50090-4743	50090-4743-0050090-4743-01
Fosinopril sodiumfosinopirl sodium	Fosinopril sodium 10 mg/1	TabletOral	Bryant Ranch Prepack	71335-0726	71335-0726-0171335-0726-0271335-0726-03+1 more
Fosinopril sodium	Fosinopril sodium 40 mg/1	TabletOral	Bryant Ranch Prepack	71335-9703	71335-9703-0171335-9703-0271335-9703-03
Fosinopril Sodiumfosinopril	Fosinopril sodium 10 mg/1	TabletOral	A-S Medication Solutions	50090-2977	50090-2977-00
Fosinopril Sodiumfosinopril	Fosinopril sodium 10 mg/1	TabletOral	Cipla USA Inc.	69097-856	69097-0856-0569097-0856-15
Fosinopril Sodiumfosinopril	Fosinopril sodium 20 mg/1	TabletOral	Cipla USA Inc.	69097-857	69097-0857-0569097-0857-15
Fosinopril Sodiumfosinopril	Fosinopril sodium 40 mg/1	TabletOral	Cipla USA Inc.	69097-858	69097-0858-0569097-0858-15
Fosinopril Sodiumfosinopril	Fosinopril sodium 20 mg/1	TabletOral	Bryant Ranch Prepack	71335-0187	71335-0187-0171335-0187-02

All 18 Fosinopril sodium NDCs

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
Product	Strength	Form · route	Labeler	Product NDC
Fosinopril sodiumfosinopirl sodium	Fosinopril sodium 10 mg/1	TabletOral	Solco Healthcare LLC	43547-386
Fosinopril sodium	Fosinopril sodium 20 mg/1	TabletOral	Solco Healthcare LLC	43547-387
Fosinopril sodium	Fosinopril sodium 40 mg/1	TabletOral	A-S Medication Solutions	50090-4743
Fosinopril sodiumfosinopirl sodium	Fosinopril sodium 10 mg/1	TabletOral	Bryant Ranch Prepack	71335-0726
Fosinopril sodium	Fosinopril sodium 40 mg/1	TabletOral	Bryant Ranch Prepack	71335-9703