Guanfacine Hydrochloride
- Product NDC
- 53746-713
- 11-digit product format
- 537460713
- Labeler code
- 53746
- Product ID
- 53746-713_98111f92-dc41-4939-b554-65b3f97a3e19
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Guanfacine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA075109
- Marketing category
- ANDA
- Marketing start
- 2022-04-15
- Substance
- GUANFACINE HYDROCHLORIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Guanfacine Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GUANFACINE HYDROCHLORIDE | 2 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 |
|---|
| 53746-713-01 | Guanfacine Hydrochloride | 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 |
|---|
| 53746-713 | GUANFACINE HYDROCHLORIDE (GUANFACINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20230217_73d50917-c807-4213-8efe-aea209845936.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53746-713-01 | 53746071301 | 100 TABLET in 1 BOTTLE (53746-713-01) | 100 tablet | 2022-04-15 | 0000-00-00 | No | No | Current |