NDC codes

FDA NDC Directory
Product NDC (as listed)76282-202Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76282-0202Add 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
76282-202-1076282020210762820202101000 TABLET in 1 BOTTLE (76282-202-10)Marketed from Jun 21, 2005
76282-202-90762820202907628202029090 TABLET in 1 BOTTLE (76282-202-90)Marketed from Jun 21, 2005

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
Exelan Pharmaceuticals, Inc.NDC labeler code 76282
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077222
Marketing start
Listing expires
Other FDA classes
Angiotensin-converting Enzyme Inhibitors (Mechanism)
Identifiers
Product ID 76282-202_ed121c1b-359c-471e-913c-4afdf9102c34SPL ID ed121c1b-359c-471e-913c-4afdf9102c34SPL set ID e2ff3171-a17a-456a-9272-ca1682b01d19RxCUI 857169, 857183, 857187UNII NW2RTH6T2NUPC 0376282202907, 0376282201900, 0376282200903

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

N476282020210 followed by a unit qualifier and the quantity

Package 76282-0202-10. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Fosinopril sodium tablets are indicated for the treatment of hypertension. It 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 similar …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76282-202

What is NDC 76282-202?
76282-202 is the product NDC for Fosinopril sodium, Fosinopril sodium 40 mg/1 tablet, listed with the FDA by Exelan Pharmaceuticals, Inc.. 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?
Exelan Pharmaceuticals, Inc., NDC labeler code 76282. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Fosinopril sodiumfosinopirl sodiumFosinopril sodium 10 mg/1TabletOralSolco Healthcare LLC43547-38643547-0386-0943547-0386-11
Fosinopril sodiumFosinopril sodium 20 mg/1TabletOralSolco Healthcare LLC43547-38743547-0387-0943547-0387-11
Fosinopril sodiumFosinopril sodium 40 mg/1TabletOralSolco Healthcare LLC43547-38843547-0388-0943547-0388-11
Fosinopril sodiumFosinopril sodium 40 mg/1TabletOralA-S Medication Solutions50090-474350090-4743-0050090-4743-01
Fosinopril sodiumfosinopirl sodiumFosinopril sodium 10 mg/1TabletOralBryant Ranch Prepack71335-072671335-0726-0171335-0726-0271335-0726-03+1 more
Fosinopril sodiumFosinopril sodium 40 mg/1TabletOralBryant Ranch Prepack71335-970371335-9703-0171335-9703-0271335-9703-03
Fosinopril SodiumfosinoprilFosinopril sodium 10 mg/1TabletOralA-S Medication Solutions50090-297750090-2977-00
Fosinopril SodiumfosinoprilFosinopril sodium 10 mg/1TabletOralCipla USA Inc.69097-85669097-0856-0569097-0856-15
Fosinopril SodiumfosinoprilFosinopril sodium 20 mg/1TabletOralCipla USA Inc.69097-85769097-0857-0569097-0857-15
Fosinopril SodiumfosinoprilFosinopril sodium 40 mg/1TabletOralCipla USA Inc.69097-85869097-0858-0569097-0858-15

All 18 Fosinopril sodium NDCs

Other NDCs under ANDA 077222

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

FDA NDC Directory listings under ANDA 077222
ProductStrengthForm · routeLabelerProduct NDC
Fosinopril SodiumfosinoprilFosinopril sodium 10 mg/1TabletOralA-S Medication Solutions50090-2977
Fosinopril SodiumfosinoprilFosinopril sodium 10 mg/1TabletOralCipla USA Inc.69097-856
Fosinopril SodiumfosinoprilFosinopril sodium 20 mg/1TabletOralCipla USA Inc.69097-857
Fosinopril SodiumfosinoprilFosinopril sodium 40 mg/1TabletOralCipla USA Inc.69097-858
Fosinopril SodiumfosinoprilFosinopril sodium 20 mg/1TabletOralBryant Ranch Prepack71335-0187
Fosinopril SodiumfosinoprilFosinopril sodium 10 mg/1TabletOralBryant Ranch Prepack71335-0381
Fosinopril sodiumFosinopril sodium 10 mg/1TabletOralExelan Pharmaceuticals, Inc.76282-200
Fosinopril sodiumFosinopril sodium 20 mg/1TabletOralExelan Pharmaceuticals, Inc.76282-201

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