NDC codes

FDA NDC Directory
Product NDC (as listed)42543-493Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42543-0493Add 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
42543-493-0142543049301100 CAPSULE in 1 BOTTLE (42543-493-01)Marketed from Jul 31, 2017
42543-493-0542543049305500 CAPSULE in 1 BOTTLE (42543-493-05)Marketed from Jul 31, 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)
Amantadine Hydrochloride
Generic name (nonproprietary)
amantadine hydrochloride
Active ingredients
Amantadine hydrochloride — 100 mg/1
Dosage form
Capsule
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209047
Marketing start
Listing expires
Other FDA classes
M2 Protein Inhibitors (Mechanism)
Identifiers
Product ID 42543-493_20218de3-d4e9-4f7d-b1f5-bfb66e22420dSPL ID 20218de3-d4e9-4f7d-b1f5-bfb66e22420dSPL set ID e4d8f36f-d668-4728-8dca-b1c22bd9aedbRxCUI 849389UNII M6Q1EO9TD0UPC 0342543493018
Pharmacologic class
Influenza A M2 Protein 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

N442543049301 followed by a unit qualifier and the quantity

Package 42543-0493-01. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine hydrochloride capsules are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later ex…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209047

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

FDA NDC Directory listings under ANDA 209047
ProductStrengthForm · routeLabelerProduct NDC
Amantadine HydrochlorideAmantadine hydrochloride 100 mg/1CapsuleOralProficient Rx LP71205-223
Amantadine HCLAmantadine hydrochloride 100 mg/1CapsuleOralDirect_Rx72189-412
Amantadine HydrochlorideAmantadine hydrochloride 100 mg/1CapsuleOralBryant Ranch Prepack71335-9618

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