NDC codes

FDA NDC Directory
Product NDC (as listed)62332-586Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62332-0586Add 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
62332-586-316233205863162332058631100 TABLET in 1 BOTTLE (62332-586-31)Marketed from Oct 20, 2020
62332-586-716233205867162332058671500 TABLET in 1 BOTTLE (62332-586-71)Marketed from Oct 20, 2020

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
Generic name (nonproprietary)
amantadine
Active ingredients
Amantadine hydrochloride — 100 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Alembic Pharmaceuticals Inc.NDC labeler code 62332
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214284
Marketing start
Listing expires
Other FDA classes
M2 Protein Inhibitors (Mechanism)
Identifiers
Product ID 62332-586_a9507ffa-0c95-48ce-80bf-60bc699add17SPL ID a9507ffa-0c95-48ce-80bf-60bc699add17SPL set ID da1837b5-fda2-48e0-91ba-d6eb2b991b55RxCUI 849395UNII M6Q1EO9TD0
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

N462332058631 followed by a unit qualifier and the quantity

Package 62332-0586-31. 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 tablets are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride tablets are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine hydrochloride tablets are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine hydrochloride tablets do 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 protec…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62332-586

What is NDC 62332-586?
62332-586 is the product NDC for Amantadine, Amantadine hydrochloride 100 mg/1 tablet, listed with the FDA by Alembic Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Amantadine.
What is the active ingredient?
Amantadine hydrochloride.
Who is the labeler?
Alembic Pharmaceuticals Inc., NDC labeler code 62332. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Amantadine?
9 other product NDCs are listed under this name. See all Amantadine 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 Amantadine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
AmantadineAmantadine hydrochloride 50 mg/5mLSolutionOralAvPAK50268-03650268-0036-14
AmantadineAmantadine hydrochloride 100 mg/1TabletOralCoupler LLC67046-153167046-1531-03
AmantadineAmantadine hydrochloride 50 mg/5mLSolutionOralXttrium Laboratories, Inc0116-401000116-4010-1600116-4010-41
AmantadineAmantadine hydrochloride 100 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-860500615-8605-39
AmantadineAmantadine hydrochloride 100 mg/1TabletOralAlembic Pharmaceuticals Limited46708-58646708-0586-3146708-0586-71
AmantadineAmantadine hydrochloride 100 mg/1TabletOralProficient Rx LP82804-26782804-0267-20
AmantadineAmantadine hydrochloride 100 mg/1CapsuleOralAmerican Health Packaging60687-42260687-0422-01
amantadineAmantadine hydrochloride 100 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-24646708-0246-3046708-0246-3146708-0246-71+1 more
amantadineAmantadine hydrochloride 100 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-24662332-0246-3062332-0246-3162332-0246-71+1 more

Other NDCs under ANDA 214284

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

FDA NDC Directory listings under ANDA 214284
ProductStrengthForm · routeLabelerProduct NDC
AmantadineAmantadine hydrochloride 100 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8605
AmantadineAmantadine hydrochloride 100 mg/1TabletOralAlembic Pharmaceuticals Limited46708-586
AmantadineAmantadine hydrochloride 100 mg/1TabletOralCoupler LLC67046-1531
AmantadineAmantadine hydrochloride 100 mg/1TabletOralProficient Rx LP82804-267

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