Prescription drug · ANDA
memantine hydrochloride NDC 31722-808
Memantine hydrochloride 10 mg/1 · Tablet · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-808-02 | 31722080802 | 200 TABLET in 1 BOTTLE (31722-808-02)Marketed from Sep 26, 2022 | |
| 31722-808-32 | 31722080832 | 10 BLISTER PACK in 1 CARTON (31722-808-32) / 10 TABLET in 1 BLISTER PACKMarketed from Sep 26, 2022 | |
| 31722-808-60 | 31722080860 | 60 TABLET in 1 BOTTLE (31722-808-60)Marketed from Sep 26, 2022 |
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
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204389
- Marketing start
- Listing expires
- Other FDA classes
- NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 31722-808_eabf0e61-425e-9c9f-e053-2a95a90ade8eSPL ID eabf0e61-425e-9c9f-e053-2a95a90ade8eSPL set ID 910827aa-5320-446c-8f66-3f17c0ee36d9RxCUI 996561, 996571UNII JY0WD0UA60UPC 0331722807609, 0331722808606
- 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
N431722080802followed by a unit qualifier and the quantityPackage 31722-0808-02. 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 ANDA 204389
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 | TabletOral | A-S Medication Solutions | 50090-7348 |
| memantine hydrochloride | Memantine hydrochloride 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7356 |
| memantine hydrochloride | Memantine hydrochloride 5 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-807 |