Prescription drug · NDA
Gocovri (Amantadine) NDC 70482-170
Amantadine 137 mg/1 · Capsule, Coated pellets · Oral · Adamas Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70482-170-21 | 70482017021 | 21 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-170-21)Marketed from Aug 24, 2017 · Sample package | |
| 70482-170-60 | 70482017060 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-170-60)Marketed from Aug 24, 2017 | |
| 70482-170-61 | 70482017061 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-170-61)Marketed from Aug 24, 2017 · Sample package |
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)
- Gocovri
- Generic name (nonproprietary)
- amantadine
- Active ingredients
- Amantadine — 137 mg/1
- Dosage form
- Capsule, Coated pellets
- Route
- Oral
- Labeler
- Adamas Pharma, LLCNDC labeler code 70482
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208944
- Marketing start
- Listing expires
- Other FDA classes
- M2 Protein Inhibitors (Mechanism)
- Identifiers
- Product ID 70482-170_5afdf1a7-3dda-5cdc-e063-6394a90abd2fSPL ID 5afdf1a7-3dda-5cdc-e063-6394a90abd2fSPL set ID 82ff865f-78f3-4c94-b6a9-727a54944b28RxCUI 1944370, 1944376, 1944380, 1944382UNII BF4C9Z1J53
- Pharmacologic class
- Influenza A M2 Protein Inhibitor
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
N470482017021followed by a unit qualifier and the quantityPackage 70482-0170-21. 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)
GOCOVRI ® is indicated: For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes GOCOVRI ® is indicated: For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications ( 1 ) As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 70482-170
- What is NDC 70482-170?
- 70482-170 is the product NDC for Gocovri (amantadine), Amantadine 137 mg/1 capsule, coated pellets, listed with the FDA by Adamas Pharma, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gocovri (Amantadine).
- What is the active ingredient?
- Amantadine.
- Who is the labeler?
- Adamas Pharma, LLC, NDC labeler code 70482. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gocovri?
- 3 other product NDCs are listed under this name. See all Gocovri NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gocovri products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Gocovriamantadine | Amantadine 68.5 mg/1 | Capsule, Coated pelletsOral | Adamas Pharma, LLC | 70482-085 | 70482-0085-2170482-0085-6070482-0085-61 |
| Gocovriamantadine | Amantadine 68.5 mg/1 | Capsule, Coated pelletsOral | Supernus Pharmaceuticals, Inc. | 17772-085 | 17772-0085-2117772-0085-60 |
| Gocovriamantadine | Amantadine 137 mg/1 | Capsule, Coated pelletsOral | Supernus Pharmaceuticals, Inc. | 17772-170 | 17772-0170-2117772-0170-60 |
Other NDCs under NDA 208944
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 |
|---|---|---|---|---|
| Gocovriamantadine | Amantadine 68.5 mg/1 | Capsule, Coated pelletsOral | Supernus Pharmaceuticals, Inc. | 17772-085 |
| Gocovriamantadine | Amantadine 137 mg/1 | Capsule, Coated pelletsOral | Supernus Pharmaceuticals, Inc. | 17772-170 |
| Gocovriamantadine | Amantadine 68.5 mg/1 | Capsule, Coated pelletsOral | Adamas Pharma, LLC | 70482-085 |