Prescription drug · NDA
Intuniv (Guanfacine) NDC 54092-517
Guanfacine hydrochloride 3 mg/1 · Tablet, Extended release · Oral · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54092-517-02 | 5409205170254092051702 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (54092-517-02)Marketed from Sep 2, 2009 |
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)
- Intuniv
- Generic name (nonproprietary)
- guanfacine
- Active ingredients
- Guanfacine hydrochloride — 3 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Takeda Pharmaceuticals America, Inc.NDC labeler code 54092
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022037
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 54092-517_448b4d80-7441-4a2f-839f-c61052d6e83aSPL ID 448b4d80-7441-4a2f-839f-c61052d6e83aSPL set ID b972af81-3a37-40be-9fe1-3ddf59852528RxCUI 862006, 862010, 862013, 862015, 862019, 862021, 862025, 862027, 1092566, 1092567UNII PML56A160OUPC 0354092513024, 0354092519026, 0354092515028, 0354092517022
- Pharmacologic class
- Central alpha-2 Adrenergic Agonist
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
N454092051702followed by a unit qualifier and the quantityPackage 54092-0517-02. 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)
INTUNIV ® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14) ]. INTUNIV is a central alpha 2A -adrenergic receptor agonist indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications ( 1 , 14 ).
Excerpt only. Read the full label for complete information.
About NDC 54092-517
- What is NDC 54092-517?
- 54092-517 is the product NDC for Intuniv (guanfacine), Guanfacine hydrochloride 3 mg/1 tablet, extended release, listed with the FDA by Takeda Pharmaceuticals America, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Intuniv (Guanfacine).
- What is the active ingredient?
- Guanfacine hydrochloride.
- Who is the labeler?
- Takeda Pharmaceuticals America, Inc., NDC labeler code 54092. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Intuniv?
- 3 other product NDCs are listed under this name. See all Intuniv NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Intuniv products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Intunivguanfacine | Guanfacine hydrochloride 1 mg/1 | Tablet, Extended releaseOral | Takeda Pharmaceuticals America, Inc. | 54092-513 | 54092-0513-02 |
| Intunivguanfacine | Guanfacine hydrochloride 2 mg/1 | Tablet, Extended releaseOral | Takeda Pharmaceuticals America, Inc. | 54092-515 | 54092-0515-02 |
| Intunivguanfacine | Guanfacine hydrochloride 4 mg/1 | Tablet, Extended releaseOral | Takeda Pharmaceuticals America, Inc. | 54092-519 | 54092-0519-02 |
Other NDCs under NDA 022037
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 |
|---|---|---|---|---|
| Intunivguanfacine | Guanfacine hydrochloride 1 mg/1 | Tablet, Extended releaseOral | Takeda Pharmaceuticals America, Inc. | 54092-513 |
| Intunivguanfacine | Guanfacine hydrochloride 2 mg/1 | Tablet, Extended releaseOral | Takeda Pharmaceuticals America, Inc. | 54092-515 |
| Intunivguanfacine | Guanfacine hydrochloride 4 mg/1 | Tablet, Extended releaseOral | Takeda Pharmaceuticals America, Inc. | 54092-519 |