Guanfacine
- Product NDC
- 42806-296
- 11-digit product format
- 428060296
- Labeler code
- 42806
- Product ID
- 42806-296_d0ca35de-12e8-4154-825a-c82eed36efd7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Guanfacine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Epic Pharma, LLC
- Application
- ANDA074673
- Marketing category
- ANDA
- Marketing start
- 2013-12-02
- 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
- 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 | 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 |
|---|
| 42806-296-01 | Guanfacine | 100 in 1 BOTTLE | TABLET | 100 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GUANFACINE HYDROCHLORIDE | ACTIVE INGREDIENT | PML56A160O | GUANFACINE TABLET [EPIC PHARMA, LLC] | 3 | |
| GUANFACINE | ACTIVE MOIETY | 30OMY4G3MK | GUANFACINE TABLET [EPIC PHARMA, LLC] | 3 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | GUANFACINE TABLET [EPIC PHARMA, LLC] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GUANFACINE TABLET [EPIC PHARMA, LLC] | 3 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | GUANFACINE TABLET [EPIC PHARMA, LLC] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GUANFACINE TABLET [EPIC PHARMA, LLC] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | GUANFACINE TABLET [EPIC PHARMA, LLC] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | GUANFACINE TABLET [EPIC PHARMA, LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42806-296 | GUANFACINE TABLET [EPIC PHARMA, LLC] | 12 | Current NDC, Legacy NDC, 1 package rows | 20231221_fac4a4c2-f5f0-46ef-b76b-315abe9136fa.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 |
|---|
| 42806-296-01 | 42806029601 | 100 TABLET in 1 BOTTLE (42806-296-01) | 100 tablet | 2019-05-30 | 0000-00-00 | No | No | Current |