Prescription drug · ANDA
Memantine Hydrochloride NDC 47335-322
Memantine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47335-322-08 | 4733503220847335032208 | 100 TABLET, FILM COATED in 1 BOTTLE (47335-322-08)Marketed from Jul 11, 2015 | |
| 47335-322-13 | 4733503221347335032213 | 500 TABLET, FILM COATED in 1 BOTTLE (47335-322-13)Marketed from Jul 11, 2015 | |
| 47335-322-18 | 4733503221847335032218 | 1000 TABLET, FILM COATED in 1 BOTTLE (47335-322-18)Marketed from Jul 11, 2015 | |
| 47335-322-83 | 4733503228347335032283 | 30 TABLET, FILM COATED in 1 BOTTLE (47335-322-83)Marketed from Jul 11, 2015 | |
| 47335-322-86 | 4733503228647335032286 | 60 TABLET, FILM COATED in 1 BOTTLE (47335-322-86)Marketed from Jul 11, 2015 | |
| 47335-322-88 | 4733503228847335032288 | 100 TABLET, FILM COATED in 1 BOTTLE (47335-322-88)Marketed 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
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090058
- Marketing start
- Listing expires
- Other FDA classes
- NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 47335-322_81ca8cbf-7854-43a2-bd0b-1dbaf4709a42SPL ID 81ca8cbf-7854-43a2-bd0b-1dbaf4709a42SPL set ID d1963395-3cf7-4433-bf2c-06295bb1c5b0RxCUI 996561, 996571UNII 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
N447335032208followed by a unit qualifier and the quantityPackage 47335-0322-08. 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.
About NDC 47335-322
- What is NDC 47335-322?
- 47335-322 is the product NDC for Memantine Hydrochloride, Memantine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 6 package NDCs, 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?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. 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.
Related NDCs: other Memantine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Memantine hydrochloride | Memantine hydrochloride 7 mg/1 | Capsule, Extended releaseOral | Macleods Pharmaceuticals Limited | 33342-219 | 33342-0219-0733342-0219-12 |
| Memantine hydrochloride | Memantine hydrochloride 14 mg/1 | Capsule, Extended releaseOral | Macleods Pharmaceuticals Limited | 33342-220 | 33342-0220-0733342-0220-12 |
| Memantine hydrochloride | Memantine hydrochloride 21 mg/1 | Capsule, Extended releaseOral | Macleods Pharmaceuticals Limited | 33342-221 | 33342-0221-0733342-0221-12 |
| Memantine hydrochloride | Memantine hydrochloride 28 mg/1 | Capsule, Extended releaseOral | Macleods Pharmaceuticals Limited | 33342-222 | 33342-0222-0733342-0222-12 |
| Memantine Hydrochloride | Memantine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Carlsbad Technology, Inc. | 61442-192 | 61442-0192-0561442-0192-60 |
| Memantine Hydrochloride | Memantine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Carlsbad Technology, Inc. | 61442-193 | 61442-0193-0561442-0193-60 |
| Memantine Hydrochloridememantine | Memantine hydrochloride 7 mg/1 | Capsule, Extended releaseOral | Rising Pharma Holdings, Inc. | 16571-852 | 16571-0852-03 |
| Memantine Hydrochloridememantine | Memantine hydrochloride 14 mg/1 | Capsule, Extended releaseOral | Rising Pharma Holdings, Inc. | 16571-853 | 16571-0853-0316571-0853-09 |
| Memantine Hydrochloridememantine | Memantine hydrochloride 21 mg/1 | Capsule, Extended releaseOral | Rising Pharma Holdings, Inc. | 16571-854 | 16571-0854-03 |
| Memantine Hydrochloridememantine | Memantine hydrochloride 28 mg/1 | Capsule, Extended releaseOral | Rising Pharma Holdings, Inc. | 16571-855 | 16571-0855-0316571-0855-09 |
Other NDCs under ANDA 090058
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Memantine Hydrochloride | Memantine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-321 |
| Memantine Hydrochloride | Memantine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1908 |