Prescription drug · NDA AUTHORIZED GENERIC
memantine hydrochloride NDC 0591-3900
Kit · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0591-3900-87 | 00591390087 | 1 BLISTER PACK in 1 CARTON (0591-3900-87) / 1 KIT in 1 BLISTER PACKMarketed from Apr 1, 2015 |
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
- Dosage form
- Kit
- Route
- Oral
- Labeler
- Actavis Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021487
- Marketing start
- Marketing end
- Identifiers
- Product ID 0591-3900_985e1190-b8a0-4775-9a20-ad1924b14fb2SPL ID 985e1190-b8a0-4775-9a20-ad1924b14fb2SPL set ID 72973b46-f307-4a9e-8fb1-ad2cbccfd736RxCUI 996561, 996571, 996572UNII JY0WD0UA60
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
N400591390087followed by a unit qualifier and the quantityPackage 00591-3900-87. 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 tablets are 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.
Other NDCs under NDA 021487
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 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-011 |
| memantine hydrochloride | Memantine hydrochloride 10 mg/1 | TabletOral | Actavis Pharma, Inc. | 0591-3875 |
| memantine hydrochloride | Memantine hydrochloride 5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-2666 |
| memantine hydrochloride | Memantine hydrochloride 10 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-2667 |
| memantine hydrochloride | Memantine hydrochloride 5 mg/1 | TabletOral | Actavis Pharma, Inc. | 0591-3870 |