Guanfacine Hydrochloride
- Product NDC
- 65162-711
- 11-digit product format
- 651620711
- Labeler code
- 65162
- Product ID
- 65162-711_2742ab0e-0dcc-4be7-8356-ea7ba8dfe6a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Guanfacine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA075109
- Marketing category
- ANDA
- Marketing start
- 1998-11-25
- 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 Hydrochloride
- 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 |
|---|
| 65162-711-03 | Guanfacine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 13 |
| 65162-711-10 | Guanfacine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GUANFACINE HYDROCHLORIDE | ACTIVE INGREDIENT | PML56A160O | GUANFACINE HYDROCHLORIDE (GUANFACINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| GUANFACINE | ACTIVE MOIETY | 30OMY4G3MK | GUANFACINE HYDROCHLORIDE (GUANFACINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GUANFACINE HYDROCHLORIDE (GUANFACINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | GUANFACINE HYDROCHLORIDE (GUANFACINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | GUANFACINE HYDROCHLORIDE (GUANFACINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| GUANFACINE HYDROCHLORIDE | ACTIVE INGREDIENT | PML56A160O | GUANFACINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS] | 2 | |
| GUANFACINE | ACTIVE MOIETY | 30OMY4G3MK | GUANFACINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GUANFACINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | GUANFACINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS] | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | GUANFACINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-711 | GUANFACINE HYDROCHLORIDE (GUANFACINE) TABLET [AMNEAL PHARMACEUTICALS LLC] | 13 | Current NDC, Legacy NDC, 2 package rows | 20241027_d9fdc4b4-5b00-46dd-8700-6e36ceaafb0e.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 |
|---|
| 65162-711-03 | 65162071103 | 30 TABLET in 1 BOTTLE (65162-711-03) | 30 tablet | 1998-11-25 | 0000-00-00 | No | No | Current |
| 65162-711-10 | 65162071110 | 100 TABLET in 1 BOTTLE (65162-711-10) | 100 tablet | 1998-11-25 | 0000-00-00 | No | No | Current |