Prescription drug · NDA
Gocovri (Amantadine) NDC 17772-170
Amantadine 137 mg/1 · Capsule, Coated pellets · Oral · Supernus Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 17772-170-21 | 1777201702117772017021 | 21 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-170-21)Marketed from Aug 24, 2017 · Sample package | |
| 17772-170-60 | 1777201706017772017060 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-170-60)Marketed from Aug 24, 2017 |
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
- Supernus Pharmaceuticals, Inc.NDC labeler code 17772
- 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 17772-170_5d1a00b7-b53a-f54e-e063-6294a90aae21SPL ID 5d1a00b7-b53a-f54e-e063-6294a90aae21
- 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
N417772017021followed by a unit qualifier and the quantityPackage 17772-0170-21. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 17772-170
- What is NDC 17772-170?
- 17772-170 is the product NDC for Gocovri (amantadine), Amantadine 137 mg/1 capsule, coated pellets, listed with the FDA by Supernus Pharmaceuticals, Inc.. It has 2 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?
- Supernus Pharmaceuticals, Inc., NDC labeler code 17772. 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 | Supernus Pharmaceuticals, Inc. | 17772-085 | 17772-0085-2117772-0085-60 |
| Gocovriamantadine | Amantadine 68.5 mg/1 | Capsule, Coated pelletsOral | Adamas Pharma, LLC | 70482-085 | 70482-0085-2170482-0085-6070482-0085-61 |
| Gocovriamantadine | Amantadine 137 mg/1 | Capsule, Coated pelletsOral | Adamas Pharma, LLC | 70482-170 | 70482-0170-2170482-0170-6070482-0170-61 |
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 68.5 mg/1 | Capsule, Coated pelletsOral | Adamas Pharma, LLC | 70482-085 |
| Gocovriamantadine | Amantadine 137 mg/1 | Capsule, Coated pelletsOral | Adamas Pharma, LLC | 70482-170 |