Guanfacine
- Product NDC
- 0378-1190
- 11-digit product format
- 003781190
- Labeler code
- 0378
- Product ID
- 0378-1190_40f8fb73-2c25-41a6-974c-3c5bf8416516
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- guanfacine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA074796
- Marketing category
- ANDA
- Marketing start
- 1997-01-27
- Marketing end
- 0000-00-00
- Substance
- GUANFACINE HYDROCHLORIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Central alpha-2 Adrenergic Agonist [EPC],Adrenergic alpha2-Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GUANFACINE HYDROCHLORIDE | ACTIVE INGREDIENT | PML56A160O | GUANFACINE (GUANFACINE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| GUANFACINE | ACTIVE MOIETY | 30OMY4G3MK | GUANFACINE (GUANFACINE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | GUANFACINE (GUANFACINE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GUANFACINE (GUANFACINE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | GUANFACINE (GUANFACINE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | GUANFACINE (GUANFACINE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GUANFACINE (GUANFACINE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | GUANFACINE (GUANFACINE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
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 |
|---|
| 0378-1190-01 | 00378119001 | 100 TABLET in 1 BOTTLE (0378-1190-01) | 100 tablet | 1997-01-27 | 0000-00-00 | No | No | Current |