NDC codes

FDA NDC Directory
Product NDC (as listed)0904-6735Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-6735Add 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
0904-6735-610090467356100904673561100 BLISTER PACK in 1 CARTON (0904-6735-61) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Feb 20, 2018

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 28 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Labeler
Major PharmaceuticalsNDC labeler code 0904
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206028
Marketing start
Listing expires
Other FDA classes
NMDA Receptor Antagonists (Mechanism)
Identifiers
Product ID 0904-6735_64e26acf-3799-4ad1-b91f-cf5766e5ada9SPL ID 64e26acf-3799-4ad1-b91f-cf5766e5ada9SPL set ID f6ce7cca-d245-44f2-986c-2a8d85dbb5fbRxCUI 996594, 996603, 996609, 996615UNII JY0WD0UA60
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

N400904673561 followed by a unit qualifier and the quantity

Package 00904-6735-61. 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 extended-release capsules are a N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. ( 1 ) Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer's type.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0904-6735

What is NDC 0904-6735?
0904-6735 is the product NDC for memantine hydrochloride, Memantine hydrochloride 28 mg/1 capsule, extended release, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
memantine hydrochloride.
What is the active ingredient?
Memantine hydrochloride.
Who is the labeler?
Major Pharmaceuticals, NDC labeler code 0904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for memantine hydrochloride?
111 other product NDCs are listed under this name. See all memantine hydrochloride 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 memantine hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Memantine hydrochlorideMemantine hydrochloride 7 mg/1Capsule, Extended releaseOralMacleods Pharmaceuticals Limited33342-21933342-0219-0733342-0219-12
Memantine hydrochlorideMemantine hydrochloride 14 mg/1Capsule, Extended releaseOralMacleods Pharmaceuticals Limited33342-22033342-0220-0733342-0220-12
Memantine hydrochlorideMemantine hydrochloride 21 mg/1Capsule, Extended releaseOralMacleods Pharmaceuticals Limited33342-22133342-0221-0733342-0221-12
Memantine hydrochlorideMemantine hydrochloride 28 mg/1Capsule, Extended releaseOralMacleods Pharmaceuticals Limited33342-22233342-0222-0733342-0222-12
Memantine HydrochlorideMemantine hydrochloride 5 mg/1Tablet, Film coatedOralCarlsbad Technology, Inc.61442-19261442-0192-0561442-0192-60
Memantine HydrochlorideMemantine hydrochloride 10 mg/1Tablet, Film coatedOralCarlsbad Technology, Inc.61442-19361442-0193-0561442-0193-60
Memantine HydrochloridememantineMemantine hydrochloride 7 mg/1Capsule, Extended releaseOralRising Pharma Holdings, Inc.16571-85216571-0852-03
Memantine HydrochloridememantineMemantine hydrochloride 14 mg/1Capsule, Extended releaseOralRising Pharma Holdings, Inc.16571-85316571-0853-0316571-0853-09
Memantine HydrochloridememantineMemantine hydrochloride 21 mg/1Capsule, Extended releaseOralRising Pharma Holdings, Inc.16571-85416571-0854-03
Memantine HydrochloridememantineMemantine hydrochloride 28 mg/1Capsule, Extended releaseOralRising Pharma Holdings, Inc.16571-85516571-0855-0316571-0855-09

All 112 memantine hydrochloride NDCs

Other NDCs under ANDA 206028

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

FDA NDC Directory listings under ANDA 206028
ProductStrengthForm · routeLabelerProduct NDC
memantine hydrochlorideMemantine hydrochloride 7 mg/1Capsule, Extended releaseOralMajor Pharmaceuticals0904-6734
memantine hydrochlorideMemantine hydrochloride 7 mg/1Capsule, Extended releaseOralLupin Pharmaceuticals, Inc.68180-246
memantine hydrochlorideMemantine hydrochloride 14 mg/1Capsule, Extended releaseOralLupin Pharmaceuticals, Inc.68180-247
memantine hydrochlorideMemantine hydrochloride 21 mg/1Capsule, Extended releaseOralLupin Pharmaceuticals, Inc.68180-248
memantine hydrochlorideMemantine hydrochloride 28 mg/1Capsule, Extended releaseOralLupin Pharmaceuticals, Inc.68180-249

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