Guanfacine
- Product NDC
- 72319-018
- 11-digit product format
- 723190018
- Labeler code
- 72319
- Product ID
- 72319-018_262d9624-c761-8f3d-e063-6394a90a2640
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gaunfacine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- i3 Pharmaceuticals, LLC
- Application
- ANDA216828
- Marketing category
- ANDA
- Marketing start
- 2022-10-31
- Substance
- GUANFACINE HYDROCHLORIDE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Guanfacine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GUANFACINE HYDROCHLORIDE | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | PML56A160O |
| Rxcui | 197745, 197746 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72319-018-04 | Guanfacine | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72319-018 | GUANFACINE (GAUNFACINE) TABLET [I3 PHARMACEUTICALS, LLC] | 3 | Current NDC, 1 package rows | 20241116_387b33dd-829d-4dab-afe4-078fd1559027.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72319-018-04 | 72319001804 | 100 TABLET in 1 BOTTLE (72319-018-04) | 100 tablet | 2022-10-31 | No | No | Historical |