Prescription drug · ANDA

Memantine Hydrochloride NDC 55111-597

Memantine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Dr. Reddys Laboratories Limited

NDC codes

FDA NDC Directory
Product NDC (as listed)55111-597Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55111-0597Add 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
55111-597-0155111059701100 TABLET, FILM COATED in 1 BOTTLE (55111-597-01)Marketed from Jul 11, 2015
55111-597-0555111059705500 TABLET, FILM COATED in 1 BOTTLE (55111-597-05)Marketed from Jul 11, 2015
55111-597-305511105973030 TABLET, FILM COATED in 1 BOTTLE (55111-597-30)Marketed from Jul 11, 2015
55111-597-605511105976060 TABLET, FILM COATED in 1 BOTTLE (55111-597-60)Marketed from Jul 11, 2015
55111-597-785511105977810 BLISTER PACK in 1 CARTON (55111-597-78) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jul 11, 2015
55111-597-79551110597791 BLISTER PACK in 1 CARTON (55111-597-79) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jul 11, 2015

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)
Memantine Hydrochloride
Generic name (nonproprietary)
memantine hydrochloride
Active ingredients
Memantine hydrochloride — 10 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090048
Marketing start
Listing expires
Other FDA classes
NMDA Receptor Antagonists (Mechanism)
Identifiers
Product ID 55111-597_998c5d15-8b47-fe20-82c5-98897caf80ebSPL ID 998c5d15-8b47-fe20-82c5-98897caf80ebSPL set ID a71e2482-5266-d03e-8b36-862afe78c9a4RxCUI 996561, 996571UNII JY0WD0UA60UPC 0355111596608
Pharmacologic class
N-methyl-D-aspartate Receptor Antagonist

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

N455111059701 followed by a unit qualifier and the quantity

Package 55111-0597-01. 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)

Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090048

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

FDA NDC Directory listings under ANDA 090048
ProductStrengthForm · routeLabelerProduct NDC
MemantineMemantine hydrochloride 5 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8192
Memantine HydrochlorideMemantine hydrochloride 5 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-4151
MemantineMemantine hydrochloride 5 mg/1TabletOralAmerican Health Packaging60687-173
MemantineMemantine hydrochloride 10 mg/1TabletOralAmerican Health Packaging60687-184
MemantineMemantine hydrochloride 5 mg/1TabletOralNorthStar RxLLC72603-118
MemantineMemantine hydrochloride 10 mg/1TabletOralNorthStar RxLLC72603-119
Memantine HydrochlorideMemantine hydrochloride 5 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6505
Memantine HydrochlorideMemantine hydrochloride 10 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6506
Memantine HydrochlorideMemantine hydrochloride 5 mg/1Tablet, Film coatedOralDr. Reddys Laboratories Limited55111-596
MemantineMemantine hydrochloride 10 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8319
Memantine HydrochlorideMemantine hydrochloride 10 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-7637

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Memantine Hydrochloride NDC 55111-597 | Med-Code