Prescription drug · ANDA
Guanfacine ER NDC 72189-597
Guanfacine hydrochloride 1 mg/1 · Tablet, Extended release · Oral · Direct_rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-597-30 | 7218905973072189059730 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-597-30)Marketed from Dec 3, 2024 |
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)
- Guanfacine ER
- Generic name (nonproprietary)
- guanfacine er
- Active ingredients
- Guanfacine hydrochloride — 1 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Direct_rxNDC labeler code 72189
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217269
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 72189-597_286214e2-a65c-f43b-e063-6394a90a33beSPL ID 286214e2-a65c-f43b-e063-6394a90a33beSPL set ID 286214e2-a65b-f43b-e063-6394a90a33beRxCUI 862006UNII PML56A160O
- 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
N472189059730followed by a unit qualifier and the quantityPackage 72189-0597-30. 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)
Guanfacine extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14)].
Excerpt only. Read the full label for complete information.
About NDC 72189-597
- What is NDC 72189-597?
- 72189-597 is the product NDC for Guanfacine ER, Guanfacine hydrochloride 1 mg/1 tablet, extended release, listed with the FDA by Direct_rx. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Guanfacine ER.
- What is the active ingredient?
- Guanfacine hydrochloride.
- Who is the labeler?
- Direct_rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Guanfacine ER?
- 2 other product NDCs are listed under this name. See all Guanfacine ER NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Guanfacine ER products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Guanfacine ERguanfacine | Guanfacine hydrochloride 1 mg/1 | Tablet, Extended releaseOral | Direct_Rx | 72189-693 | 72189-0693-30 |
| Guanfacine ER | Guanfacine hydrochloride 1 mg/1 | Tablet, Extended releaseOral | Direct_Rx | 72189-469 | 72189-0469-30 |
Other NDCs under ANDA 217269
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 |
|---|---|---|---|---|
| Guanfacine | Guanfacine hydrochloride 1 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-745 |
| Guanfacine | Guanfacine hydrochloride 2 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-746 |
| Guanfacine | Guanfacine hydrochloride 3 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-747 |
| Guanfacine | Guanfacine hydrochloride 4 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-748 |
| Guanfacine | Guanfacine hydrochloride 3 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7644 |
| Guanfacine | Guanfacine hydrochloride 1 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-952 |
| Guanfacine | Guanfacine hydrochloride 2 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-953 |
| Guanfacine | Guanfacine hydrochloride 3 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-954 |
| Guanfacine | Guanfacine hydrochloride 4 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-955 |
| Guanfacine | Guanfacine hydrochloride 1 mg/1 | Tablet, Extended releaseOral | St. Mary's Medical Park Pharmacy | 60760-863 |
| Guanfacine | Guanfacine hydrochloride 1 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-745 |
| Guanfacine | Guanfacine hydrochloride 2 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-746 |
| Guanfacine | Guanfacine hydrochloride 3 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-747 |
| Guanfacine | Guanfacine hydrochloride 4 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-748 |
| Guanfacine | Guanfacine hydrochloride 1 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2379 |